Changes in Insulin Sensitivity After Weight Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Columbia University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT00627484
First received: February 28, 2008
Last updated: October 13, 2015
Last verified: October 2015

February 28, 2008
October 13, 2015
March 2005
August 2016   (final data collection date for primary outcome measure)
Change in Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)
Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627484 on ClinicalTrials.gov Archive Site
  • Change in Body Composition [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
    Measured by dual energy x-ray absorptiometry (DXA)
  • Change in Resting Energy Expenditure [ Time Frame: Up to 4 hrs post-meal ] [ Designated as safety issue: No ]
    Measured by indirect calorimetry using a Hood Calorimeter
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
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. 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
The researchers may want to retain your blood and/or tissue sample(s) so that additional research studies can be done now or in the future.
Probability Sample
Subjects will be recruited by physician referral and from outpatient obesity, bariatric surgical clinics and endocrinology clinics at Columbia University Medical Center as well as from the Medical Center Community and metropolitan area via IRB-approved flyers and internet postings. Subjects will also be recruited from the following website: www.craigslist.com using the same posting format of the IRB-approved flyers.
  • Obesity
  • Type 2 Diabetes Mellitus
  • Insulin Resistance
  • Procedure: Gastric bypass
    NOTE: the surgery is not paid for by the study
    Other Name: GBP
  • Procedure: Gastric banding
    NOTE: the surgery is not paid for by the study
    Other Name: BND
  • Procedure: Sleeve gastrectomy
    NOTE: the surgery is not paid for by the study
    Other Name: SG
  • Behavioral: Very low calorie 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.
    Other Name: VLCD
  • Group 1: GBP non-diabetic
    Non-diabetic subjects scheduled to receive gastric bypass
    Intervention: Procedure: Gastric bypass
  • Group 2: BND non-diabetic
    Non-diabetic subjects scheduled to receive gastric banding
    Intervention: Procedure: Gastric banding
  • Group 3: GBP diabetic
    Diabetic subjects scheduled to receive gastric bypass
    Intervention: Procedure: Gastric bypass
  • Group 4: VLCD diabetic
    Diabetic subjects scheduled to receive very low calorie diet
    Intervention: Behavioral: Very low calorie diet
  • Group 5: SG diabetic
    Diabetic subjects scheduled to receive sleeve gastrectomy
    Intervention: Procedure: Sleeve gastrectomy
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
110
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Non-diabetic obese (BMI > 30) adult men and women between the ages of 18 and 75 scheduled to undergo

    • gastric bypass (GBP)
    • gastric banding (BND)
  • Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
  • Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
  • Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).

Exclusion criteria:

  • Pregnancy.
  • Age > 75 for surgery groups; Age > 65 for VLCD group.
  • Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
  • Greater than a 5% change in total body weight in the 90 days prior to the study.
  • History of untreated gallstones; hepatic or renal insufficiency, abnormal TSH.
  • Use of thiazolidinedione therapy.
  • HbA1c > 12%.
  • Use of DPP-IV inhibitor or GLP-1R agonist for greater than 12 months within 3 months of the study.
  • Fasting triglycerides > 400.
  • Significant cardiovascular, neurologic, renal, gastrointestinal, or hematologic disease.
  • Inability to comply with or understand the study protocol as ascertained by the PI.
  • We will not exclude individuals with body weight > 145 kg, but we do recognize that such individuals are above the table weight limitations of the DXA scan and body composition data will be unavailable for those individuals.
Both
18 Years to 75 Years   (Adult, Senior)
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
Not Provided
Not Provided
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
October 2015

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