Changes in Insulin Sensitivity After Weight Loss

This study is currently recruiting participants.
Verified July 2012 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT00627484
First received: February 28, 2008
Last updated: July 31, 2012
Last verified: July 2012

February 28, 2008
July 31, 2012
August 2006
August 2014   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00627484 on ClinicalTrials.gov Archive Site
  • Body Composition [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
  • Resting Energy Expenditure [ Time Frame: Up to 4 hrs post-meal ] [ Designated as safety issue: No ]
    Subjects will be in a post-absorptive state for 12 hours and after IV insertion and blood draw they will rest for 30 min followed by measurement of REE for 30 mins. They will then consume a liquid meal over a 15min period, followed by a 30 min rest and repeat REE measurements for 30 min per hr for 4 hrs.
Body Composition [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Changes in Insulin Sensitivity After Weight Loss
Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery

The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.

Obesity and weight gain both contribute independently to the development of type 2 diabetes. Obesity is associated with a pre-diabetic disease state, often called insulin resistance. Studies have found that some diabetic patients who undergo gastric bypass (GBP) are cured of their diabetes within 12 weeks after surgery, prior to any significant amount of weight loss. Since the flow of nutrients from the stomach to the small intestine is interrupted after GBP, the anatomic modification may cause a greater improvement in insulin sensitivity than with other forms of weight loss. Changes in levels of hormones released from the gastrointestinal tract in response to food intake may underlie this increased insulin sensitivity.

This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. Patients who are scheduled for GBP, sleeve gastrectomy (SG), or simple caloric restriction with gastric banding (BND) or a very low calorie diet (VLCD) will be examined at baseline weight, and when 6-10% total body weight has been lost. We will measure insulin sensitivity with an intravenous glucose tolerance test, and fasting levels of hormones that regulate food intake and insulin sensitivity, such as ghrelin, PYY, GLP1 and leptin. Fat mass and skeletal muscle mass will be measured by dual photon absorptiometry (DXA). We will also measure the hormonal and thermic response to food with a liquid test meal and energy expenditure by indirect calorimetry. This measures how many calories are burned at rest and the in response to food. Subjects with diabetes will continue to be studied with the same protocol on an annual basis out to 5 years in order to determine the rate of remission of diabetes and the durability of this effect as subjects tend to regain some body weight over time.

Subjects with diabetes will also be followed every three months for the first year after the initial weight loss for HbA1c and fasting glucose levels. The results of this study may lead to new understanding about changes in insulin sensitivity, body composition and hormonal profile, as well as changes in energy expenditure with weight loss after bariatric surgery or with simple caloric restriction. With this greater understanding, new treatments for obesity and diabetes, that do not require surgery, may be developed.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Obesity
  • Type 2 Diabetes Mellitus
  • Insulin Resistance
  • Procedure: gastric bypass surgery or sleeve gastrectomy

    Gastric bypass surgery or sleeve gastrectomy

    NOTE: the surgery is not paid for by the study

  • Behavioral: Liquid Diet
    Weight Loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
  • Active Comparator: Surgery

    Either gastric bypass or sleeve gastrectomy

    NOTE: The surgery is not paid for by the study

    Intervention: Procedure: gastric bypass surgery or sleeve gastrectomy
  • Active Comparator: Liquid Diet
    Weight Loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.
    Intervention: Behavioral: Liquid Diet
Jackness C, Karmally W, Febres G, Conwell IM, Ahmed L, Bessler M, McMahon DJ, Korner J. Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and β-cell Function in type 2 diabetic patients. Diabetes. 2013 Sep;62(9):3027-32. doi: 10.2337/db12-1762. Epub 2013 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • must have diabetes
  • adults with diabetes undergoing gastric bypass or sleeve gastrectomy (the study does not pay for the surgery)
  • obese adults with diabetes willing to undergo an inpatient weight loss diet for 2 to 3 weeks

Exclusion Criteria:

  • use of triglyceride lowering medication or weight loss medication
Both
18 Years to 75 Years
Yes
Contact: Gerardo Febres, MD 212-342-0281
Contact: Judith Korner, MD, PhD 212 305-3725 jk181@columbia.edu
United States
 
NCT00627484
AAAB2401, R21DK081050, DK072011
Yes
Judith Korner, Columbia University
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Judith Korner, MD,PhD Columbia University
Columbia University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP