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Changes in Insulin Sensitivity After Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Columbia University.
Recruitment status was  Recruiting
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
  Purpose

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 surgery or sleeve gastrectomy
Behavioral: Liquid Diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:
  • Insulin Sensitivity [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery

Either gastric bypass or sleeve gastrectomy

NOTE: The surgery is not paid for by the study

Procedure: gastric bypass surgery or sleeve gastrectomy

Gastric bypass surgery or sleeve gastrectomy

NOTE: the surgery is not paid for by the study

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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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
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: July 31, 2012
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Weight Loss
Body Weight
Body Weight Changes
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Signs and Symptoms
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014