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Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02871882
Collaborator
Satiogen Pharmaceuticals, Inc. (Other)
24
Enrollment
1
Location
2
Arms
13.5
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Gastric Emptying test
  • Other: Mixed Oral Glucose Tolerance test
  • Drug: Conjugated bile acids sodium
  • Other: Placebo
 Phase 2

Detailed Description

This is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected at defined times to measure glycemia, FGF-19 and incretins (GLP-1 [glucagon-like peptide-1], OXM [oxyntomodulin], PYY 3-36 [peptide YY]) fasting levels and responses to the meal.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus
Actual Study Start Date :
Sep 15, 2016
Actual Primary Completion Date :
Oct 18, 2017
Actual Study Completion Date :
Oct 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ox bile extract

Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests

Radiation: Gastric Emptying test
participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.

Other: Mixed Oral Glucose Tolerance test
Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.

Drug: Conjugated bile acids sodium
500 mg tablets taken orally twice daily for 28 (+/- 4) days
Other Names:
  • Ox Bile extract

    • Other: Placebo
    Placebo tablets taken orally twice daily for 28 (+/- 4) days
    Placebo Comparator: Placebo

    Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests

    Radiation: Gastric Emptying test
    participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.

    Other: Mixed Oral Glucose Tolerance test
    Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.

    Drug: Conjugated bile acids sodium
    500 mg tablets taken orally twice daily for 28 (+/- 4) days
    Other Names:
  • Ox Bile extract

    • Other: Placebo
    Placebo tablets taken orally twice daily for 28 (+/- 4) days

    Outcome Measures

    Primary Outcome Measures

    1. Change in postprandial glucose [area above basal (AAB) from fasting glucose during treatment] [baseline to 1 month]

      the conjugated bile acid sodium extract in delayed (ileocolonic)-release formulation, stimulates enteroendocrine L cell secretion in the ileum and colon, increasing the secretion of FGF-19, GLP-1, oxyntomodulin (OXM), and PYY 3-36, and improves insulin sensitivity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.

    2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.

    Exclusion criteria:

    1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.

    2. Irritable bowel syndrome

    3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.

    4. Subjects with other treatment for type 2 diabetes mellitus.

    5. Subjects with HbA1c > 8%

    6. Females who are pregnant or breastfeeding

    7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.

    8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.

    9. Subjects who have donated blood or plasma in the past 8 weeks.

    10. Subjects who have participated in another study within the past 30 days.

    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
    • Satiogen Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Andres Acosta, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andres J. Acosta, M.D., Ph.D., PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02871882
    Other Study ID Numbers:
    • 15-007765
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Overweight
    Bile Acids and Salts

    Study Results

    No Results Posted as of Jan 13, 2020