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Diabetes and Gastric By- Pass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01153516
First received: June 24, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Glucose area under the curve during Mixed Meal Challenge Test [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    Will evaluate the change in the glucose AUC between the baseline evaluation (day 1) and the follow-up evaluation (day 9).


Biospecimen Retention:   Samples Without DNA

whole blood samples, plasma, serum, urine,


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153516

Locations
United States, Texas
Clinical and Translational Research Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center, Dallas
  More Information

No publications provided

Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01153516     History of Changes
Other Study ID Numbers: 122009-049
Study First Received: June 24, 2010
Last Updated: January 22, 2013
Health Authority: United States: UT Southwestern Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Type 2 diabetes
Bariatric surgery
Obesity
Weight loss

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013