The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02762708
Collaborator
(none)
12
1
4
22.2
0.5

Study Details

Study Description

Brief Summary

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Condition or Disease Intervention/Treatment Phase
  • Procedure: Roux-en-Y Gastric Bypass (RYGB)
  • Behavioral: Caloric Restriction
  • Drug: Exendin-9,39
  • Drug: Normal Saline
Phase 2

Detailed Description

Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Bariatric Surgery on Metabolism, the Metabolome and the Microbiome in Patients With Type 2 Diabetes
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 6, 2018
Actual Study Completion Date :
Jan 6, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Roux-en-Y Gastric Bypass (RYGB)

Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.

Procedure: Roux-en-Y Gastric Bypass (RYGB)
Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.
Other Names:
  • Bariatric Surgery
  • Sham Comparator: Caloric restriction

    Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.

    Behavioral: Caloric Restriction
    Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.

    Active Comparator: Exendin-9,39

    Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

    Drug: Exendin-9,39
    A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.

    Placebo Comparator: Normal Saline

    Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

    Drug: Normal Saline
    subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Fasting Glucose [At baseline and 12 weeks post intervention]

      Blood sample taken after an overnight fast.

    2. Fasting Glucose [4 weeks post intervention]

      Blood sample taken after an overnight fast.

    3. Peak Glucose [baseline and 12 weeks post intervention]

      Blood sample taken after a meal.

    4. Peak Glucose [4 weeks post intervention]

      Blood sample taken after a meal.

    5. Glucose AUC [0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention]

      Area under the curve calculated from Oral Glucose Tolerance Test

    6. Changes in the Gut Microbiome Following RYGB or Caloric Restriction [baseline and 12 weeks post intervention]

      Stool sample collection for gut microbiome analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 20-65 years of age.

    • Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.

    • Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.

    Exclusion Criteria:
    • Previous treatment with thiazolidinediones.

    • Chronic antibiotic therapy.

    • Active microvascular or macrovascular complications of diabetes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Meera Shah, MBChB, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Meera Shah, M.B., Ch.B., Assistant Professor of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02762708
    Other Study ID Numbers:
    • 15-000179
    First Posted:
    May 5, 2016
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meera Shah, M.B., Ch.B., Assistant Professor of Medicine, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Subjects that have undergone Roux-en-Y Gastric Bypass (RYGB) and were enrolled in the RYGB arm of trial period 'Study 1-RYGB vs Caloric Restriction', will be enrolled in the second trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks postoperatively.
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
    Period Title: Study 1 - RYGB vs Caloric Restriction
    STARTED 3 9 0 0
    COMPLETED 3 7 0 0
    NOT COMPLETED 0 2 0 0
    Period Title: Study 1 - RYGB vs Caloric Restriction
    STARTED 0 0 1 0
    COMPLETED 0 0 1 0
    NOT COMPLETED 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline Total
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Total of all reporting groups
    Overall Participants 3 9 1 0 13
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    100%
    9
    100%
    12
    1200%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    <=18 years
    0
    0%
    0
    0%
    Between 18 and 65 years
    1
    33.3%
    1
    11.1%
    >=65 years
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    2
    66.7%
    6
    66.7%
    0
    0%
    8
    Infinity
    Male
    1
    33.3%
    3
    33.3%
    0
    0%
    4
    Infinity
    Female
    1
    33.3%
    1
    11.1%
    Male
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    Not Hispanic or Latino
    1
    33.3%
    0
    0%
    0
    0%
    1
    Infinity
    Unknown or Not Reported
    2
    66.7%
    9
    100%
    0
    0%
    11
    Infinity
    Hispanic or Latino
    0
    0%
    0
    0%
    Not Hispanic or Latino
    1
    33.3%
    1
    11.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    3
    100%
    9
    100%
    12
    1200%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    White
    1
    33.3%
    1
    11.1%
    More than one race
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    3
    100%
    9
    100%
    12
    1200%
    Region of Enrollment (participants) [Number]
    United States
    1
    33.3%
    1
    11.1%

    Outcome Measures

    1. Primary Outcome
    Title Fasting Glucose
    Description Blood sample taken after an overnight fast.
    Time Frame At baseline and 12 weeks post intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
    Measure Participants 3 7
    Baseline
    6.1
    (0.88)
    7.23
    (0.98)
    12 weeks post intervention
    6.48
    (1.7)
    5.89
    (0.4)
    2. Primary Outcome
    Title Fasting Glucose
    Description Blood sample taken after an overnight fast.
    Time Frame 4 weeks post intervention

    Outcome Measure Data

    Analysis Population Description
    The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm.
    Arm/Group Title Exendin-9,39 Normal Saline
    Arm/Group Description Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
    Measure Participants 1 0
    Number [mmol/l]
    4.75
    3. Primary Outcome
    Title Peak Glucose
    Description Blood sample taken after a meal.
    Time Frame baseline and 12 weeks post intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
    Measure Participants 3 7
    Baseline
    11.35
    (1.5)
    10.84
    (1.39)
    12 weeks post intervention
    11.8
    (3.25)
    10.04
    (0.54)
    4. Primary Outcome
    Title Peak Glucose
    Description Blood sample taken after a meal.
    Time Frame 4 weeks post intervention

    Outcome Measure Data

    Analysis Population Description
    The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm.
    Arm/Group Title Exendin-9,39 Normal Saline
    Arm/Group Description Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
    Measure Participants 1 0
    Number [mmol/l]
    8.15
    5. Primary Outcome
    Title Glucose AUC
    Description Area under the curve calculated from Oral Glucose Tolerance Test
    Time Frame 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
    Measure Participants 3 7
    Baseline
    2815
    (223)
    2715
    (375)
    12 weeks post intervention
    3146
    (1186)
    2380
    (139)
    6. Primary Outcome
    Title Changes in the Gut Microbiome Following RYGB or Caloric Restriction
    Description Stool sample collection for gut microbiome analysis
    Time Frame baseline and 12 weeks post intervention

    Outcome Measure Data

    Analysis Population Description
    No participants samples were analyzed due to inability to obtain funding to proceed with gut microbiome analysis.
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
    Measure Participants 0 0

    Adverse Events

    Time Frame Adverse events were collected from baseline to end of study participation for a total of approximately 12 weeks on all participants.
    Adverse Event Reporting Description Number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero for the saline arm because no participants were enrolled in the saline arm of study 2- Exendin (9,39) Amide study period.
    Arm/Group Title Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline
    Arm/Group Description Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Roux-en-Y Gastric Bypass (RYGB): Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery. Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Caloric Restriction: Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Exendin-9,39: A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery. Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
    All Cause Mortality
    Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/9 (0%) 0/1 (0%) 0/0 (NaN)
    Serious Adverse Events
    Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/9 (0%) 0/1 (0%) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Roux-en-Y Gastric Bypass (RYGB) Caloric Restriction Exendin-9,39 Normal Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/9 (0%) 0/1 (0%) 0/0 (NaN)

    Limitations/Caveats

    Only one patient was enrolled in the trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks post operatively. There were logistical challenges to recruiting patients 4 weeks post operatively as operation dates were not always known to the study team in time and patients did not feel well enough to come in for a study.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Meera Shah, MB, ChB
    Organization Mayo Clinic
    Phone 507-284-0106
    Email Shah.Meera@mayo.edu
    Responsible Party:
    Meera Shah, M.B., Ch.B., Assistant Professor of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02762708
    Other Study ID Numbers:
    • 15-000179
    First Posted:
    May 5, 2016
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022