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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

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.

Condition or disease
Type 2 Diabetes

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.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Biospecimen Retention:   Samples Without DNA
whole blood samples, plasma, serum, urine,


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153516


Locations
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United States, Texas
Clinical and Translational Research Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center, Dallas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01153516    
Other Study ID Numbers: 122009-049
First Posted: June 30, 2010    Key Record Dates
Results First Posted: March 7, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Ildiko Lingvay, University of Texas Southwestern Medical Center:
Type 2 diabetes
Bariatric surgery
Obesity
Weight loss
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases