ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of a Moderate Weight Loss on Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02193295
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Howard Hughes Medical Institute
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to examine whether weight reduction decreases intramyocellular (IMCL) and hepatic lipid content, and improves insulin sensitivity of muscle and fat tissue in people who are insulin resistant and have a family history of type 2 diabetes.

Condition or disease Intervention/treatment Phase
Insulin Resistance Behavioral: Dietary consultations Not Applicable

Detailed Description:
In this study, we will examine whether a small weight loss in lean, insulin-resistant offspring of type 2 diabetic patients will improve insulin resistance. The control group will consist of subjects matched for gender, age and body weight with no family history of diabetes. Before and after weight loss, rates of basal and insulin stimulated whole body glucose metabolism will be measured using [6,6-2H] glucose during a 3 hour basal period and a 4 hour euglycemic hyperinsulinemic (20 mU/m2-min) clamp. Rates of whole body lipolysis will be determined using [2H5] glycerol, localized rates of lipolysis will be measured using the microdialysis technique and muscle PI 3-kinase activity will be assessed in muscle biopsies. FFA metabolites (fatty acyl CoA, ceramides, diacylglycerol) will be measured in fat tissue collected from the abdominal subcutaneous fat cell depot. Body composition will be determined with bioelectrical impedance and whole body MRI; IMCL will be measured with MRS. Before and after weight loss, insulin secretion will be measured with the hyperglycemic clamp (as described under Day 2 Hyperglycemic Clamp).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of a Moderate Weight Loss on Muscle and Liver Fat Content and Reversal of Insulin Resistance
Study Start Date : October 2002
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Lifestyle Intervention
Caloric Restriction.
Behavioral: Dietary consultations
Dietary consultations and caloric restriction to reduce liver and intra myocellular fat content and improve tissue specific insulin sensitivity
Other Name: PLacebo/ACC inhibitor treatment for 12 weeks

Experimental: NAFLD
Placebo or ACC inhibitor treatment for 12 weeks
Behavioral: Dietary consultations
Dietary consultations and caloric restriction to reduce liver and intra myocellular fat content and improve tissue specific insulin sensitivity
Other Name: PLacebo/ACC inhibitor treatment for 12 weeks




Primary Outcome Measures :
  1. Improvements in insulin sensitivity [ Time Frame: up to 6 months intervention to examine whether insulin sensitivity has improved significantly after the moderate weight reduction ]
    Insulin sensitivity will be assessed using the insulin/glucose clamp, liver and muscle fat will be measured using 1H magnetic resonance spectroscopy (MRS) and both results from the clamp and MRS compared to baseline values before the weight reduction intervention.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, sedentary, non-smoking and not taking any medications other than birth control pills.
  • Hematocrit >35%
  • Subjects will have no systemic or organ disease including diabetes.
  • Subjects will have no history eating disorders.
  • Women must be using a form of birth control (sexual abstinence, birth control pills, Norplant, IUD or condoms) and will be studied between day 0 and 7 of their menstrual cycle.
  • Those who are taking birth control pills or have had a hysterectomy may be studied at any time.
  • Physical activity will be assessed using a standard questionnaire with an activity index cut off at 2.3.

Exclusion Criteria:

  • Any subject, who does not fit the inclusion criteria. Including history of eating disorders, any systemic and organ disease including diabetes.

Lactose intolerance Any blood count, clotting abnormalities HYpertriglyceridemeia (TG over 100 mg/dL)

  • Hematocrit <35%.
  • Women of childbearing potential, who are not using contraception (as mentioned above) or who are not abstinent.
  • Subjects who have a regular exercise regimen will not be enrolled.
  • Metal implants and/or body piercing, which cannot be removed before the MR studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193295


Contacts
Contact: Kitt Petersen, MD 203-688-4106 kitt.petersen@yale.edu

Locations
United States, Connecticut
Yale Center for Clinical Investigation HRU Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kitt Petersen, MD    203-688-4106      
Principal Investigator: Kitt Petersen, MD         
Sponsors and Collaborators
Yale University
Howard Hughes Medical Institute
Investigators
Principal Investigator: Kitt Petersen, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02193295     History of Changes
Other Study ID Numbers: 020290-20997
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Yale University:
Weight Reduction
Caloric Restriction
Euglycemic Hyperinsulinemic Clamp
Magnetic Resonance Spectroscopy

Additional relevant MeSH terms:
Insulin Resistance
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs