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
  Purpose
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.

Condition Intervention
Obesity
Type 2 Diabetes Mellitus
Insulin Resistance
Procedure: Gastric bypass
Procedure: Gastric banding
Procedure: Sleeve gastrectomy
Behavioral: Very low calorie diet

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
    Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
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.

Estimated Enrollment: 110
Study Start Date: March 2005
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: GBP non-diabetic
Non-diabetic subjects scheduled to receive gastric bypass
Procedure: Gastric bypass
NOTE: the surgery is not paid for by the study
Other Name: GBP
Group 2: BND non-diabetic
Non-diabetic subjects scheduled to receive gastric banding
Procedure: Gastric banding
NOTE: the surgery is not paid for by the study
Other Name: BND
Group 3: GBP diabetic
Diabetic subjects scheduled to receive gastric bypass
Procedure: Gastric bypass
NOTE: the surgery is not paid for by the study
Other Name: GBP
Group 4: VLCD diabetic
Diabetic subjects scheduled to receive very low calorie diet
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 5: SG diabetic
Diabetic subjects scheduled to receive sleeve gastrectomy
Procedure: Sleeve gastrectomy
NOTE: the surgery is not paid for by the study
Other Name: SG

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627484

Contacts
Contact: Gerardo Febres, MD 212-342-0281
Contact: Judith Korner, MD, PhD 212 305-3725 jk181@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Gerardo Febres, MD    212-342-0281      
Contact: Judith Korner, MD, PhD    212 305-3725    jk181@columbia.edu   
Principal Investigator: Judith Korner, MD, PhD         
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00627484     History of Changes
Other Study ID Numbers: AAAB2401  R21DK081050  DK072011 
Study First Received: February 28, 2008
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Insulin resistance
Insulin sensitivity
bariatric surgery
diabetes
calorie restriction
body composition

Additional relevant MeSH terms:
Insulin Resistance
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 07, 2016