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IISG: Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Sponsor
Kirloskar Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00834626
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
40
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ileal Interposition with Sleeve Gastrectomy
 N/A

Detailed Description

Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: Surgery group

Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy

Procedure: Ileal Interposition with Sleeve Gastrectomy
Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
Other Names:
  • Laparoscopic Ileal Interposition surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Having Remission of Type 2 Diabetes [One year]

      The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped

    Secondary Outcome Measures

    1. Percentage of Participants Not Requiring Insulin [1 year]

      After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months

    2. Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents [one year]

      Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year

    3. Percentage of Participants Achieving Remission in Hypertension [1 year]

      Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration

    • Body Mass Index 21 - 55 kg/m^2

    • Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.

    • Gives Informed Consent for the surgery

    • Postmeal C peptide > 1.0 ng/mL

    • Age 25 - 75 years

    • Stable weight for more than 3 months

    Exclusion Criteria:

    • Type 1 Diabetes

    • Postmeal C peptide < 1 ng/mL

    • Pregnancy

    • Significant nephropathy requiring dialysis

    • Coexisting systemic disease

    • Previous gastric or intestinal resection surgery

    • Obesity due to organic illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kirloskar Hospital Hyderabad AP India 500063

    Sponsors and Collaborators

    • Kirloskar Hospital

    Investigators

    • Principal Investigator: Dr Surendra Ugale, MS, Kirloskar Hospital, Hyderabad

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kirloskar Hospital
    ClinicalTrials.gov Identifier:
    NCT00834626
    Other Study ID Numbers:
    • KH-001
    First Posted:
    Feb 3, 2009
    Last Update Posted:
    Sep 6, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Kirloskar Hospital
    Ileal Interposition
    Sleeve Gastrectomy
    Type-2 Diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    Participant Flow

    Recruitment Details Recruitment started in Jan 2008, at Kirloskar Hospital. Recruitment completed in May 2010.
    Pre-assignment Detail
    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    Period Title: Overall Study
    STARTED 30
    1 Year Follow-up 30
    COMPLETED 30
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    Overall Participants 30
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    30
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47.233
    (9.605)
    Sex: Female, Male (Count of Participants)
    Female
    14
    46.7%
    Male
    16
    53.3%
    Region of Enrollment (participants) [Number]
    India
    30
    100%

    Outcome Measures

    1. Secondary Outcome
    Title Percentage of Participants Not Requiring Insulin
    Description After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Percentage of Participants Not Requiring Insulin
    Arm/Group Description Percentage of participants not requiring Insulin assessed at 1 year post-surgery
    Measure Participants 30
    Number [Percentage of Participants]
    90
    300%
    2. Secondary Outcome
    Title Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
    Description Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year
    Time Frame one year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    Measure Participants 30
    Number [Percentage of Participants]
    93
    310%
    3. Primary Outcome
    Title Percentage of Participants Having Remission of Type 2 Diabetes
    Description The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
    Time Frame One year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    Measure Participants 30
    Number [Percentage of Participants]
    76.66
    255.5%
    4. Secondary Outcome
    Title Percentage of Participants Achieving Remission in Hypertension
    Description Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    Measure Participants 30
    Number [Percentage of Participants]
    90
    300%

    Adverse Events

    Time Frame 1 year
    Adverse Event Reporting Description
    Arm/Group Title Surgery Group
    Arm/Group Description Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
    All Cause Mortality
    Surgery Group
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Surgery Group
    Affected / at Risk (%) # Events
    Total 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Surgery Group
    Affected / at Risk (%) # Events
    Total 0/30 (0%)

    Limitations/Caveats

    Non-availability of hormonal tests like Glucagon-Like Peptide-1 estimation pre- & post-operative.

    More Information

    Certain Agreements

    Principal Investigators are NOT 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 Dr. Neeraj Gupta
    Organization Kirloskar Hospital
    Phone +91-40-23296241
    Email drugale@kirloskarhospital.com
    Responsible Party:
    Kirloskar Hospital
    ClinicalTrials.gov Identifier:
    NCT00834626
    Other Study ID Numbers:
    • KH-001
    First Posted:
    Feb 3, 2009
    Last Update Posted:
    Sep 6, 2012
    Last Verified:
    Aug 1, 2012