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Diabetes and Gastric By- Pass

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ClinicalTrials.gov Identifier: NCT01153516
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : March 7, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date June 24, 2010
First Posted Date June 30, 2010
Results First Submitted Date August 2, 2017
Results First Posted Date March 7, 2019
Last Update Posted Date March 27, 2019
Study Start Date June 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2019)
  • Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery [ Time Frame: 4-12 weeks ]
    Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
  • Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery [ Time Frame: 4-12 weeks ]
    Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
  • Response in Glucagon AUC at Baseline vs. Following Gastric Bypass [ Time Frame: 4-12 weeks ]
    Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Original Primary Outcome Measures
 (submitted: June 28, 2010)
Glucose area under the curve during Mixed Meal Challenge Test [ Time Frame: 9 days ]
Will evaluate the change in the glucose AUC between the baseline evaluation (day 1) and the follow-up evaluation (day 9).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diabetes and Gastric By- Pass
Official Title Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery
Brief Summary The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those induced by a week of matched very -low calorie liquid diet occuring in the context of routine postoperative care following RYGB.
Detailed Description

Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period.

Study Period #1:

This first study period is 9 days/nights long and requires you to be closely supervised at our Clinical and Translational Research Center (CTRC). During this time you will receive the same diet and are expected to have the same activity level you will be prescribed in the immediate post-operative period.

Wash-out period:

During this study period you are expected to return to your usual diet and exercise level.

Study Period #2:

This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery.

Procedures during the research:

Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for each study period. This test allows the investigators to evaluate how much insulin your body is producing and how well this insulin is processed.

Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood samples, plasma, serum, urine,
Sampling Method Non-Probability Sample
Study Population

Bariatric surgery clinical roster or by the treating physician in the bariatric surgery clinic.

This study does NOT pay for the By-pass surgery, eligible participants should have planned their surgery by their own physician, at their own expense.

Condition Type 2 Diabetes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Lingvay I, Guth E, Islam A, Livingston E. Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery? Diabetes Care. 2013 Sep;36(9):2741-7. doi: 10.2337/dc12-2316. Epub 2013 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2018)
22
Original Estimated Enrollment
 (submitted: June 28, 2010)
10
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.

Exclusion Criteria:

  • abnormal renal function
  • significant anemia
  • difficult venous access
  • treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
  • recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.
  • pregnancy
  • non -English speakers
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01153516
Other Study ID Numbers 122009-049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ildiko Lingvay, University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center, Dallas
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2019