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Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.

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ClinicalTrials.gov Identifier: NCT02196051
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Exercise Training Not Applicable

Detailed Description:
In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) will undergo 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis will be determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies will be performed in 3 sets: Study Part 1: Resting, Study Part 2: After 1 bout of exercise and Study part 3: After 6 weeks of exercise training. Since intra-abdominal obesity has been postulated to be at the core of the metabolic derangements and directly responsible for the atherogenic dyslipidemia associated with the metabolic syndrome, the investigators will also measure intra-abdominal fat content by magnetic resonance imaging (MRI).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Lipid and Carbohydrate Metabolism: Effects of Exercise
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 29, 2020
Actual Study Completion Date : June 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Training
Participants will engage in a single bout of elliptical exercise for 45 minutes (3X15 spaced by 5 minutes rest) at baseline. Subjects will be studied before and after this one bout to measure hepatic de novo lipogenesis. Participants will then take part in six weeks of exercise training on an elliptical trainer 3 times per week each time for 45 minutes. Hepatic de novo lipogenesis will be compared pre and post to examine wether improving muscle glucose uptake will decrease hepatic de novo lipogenesis as the glucose is taken up by muscle and not directed to the liver.
Other: Exercise Training
Six weeks of exercise




Primary Outcome Measures :
  1. change in de novo lipogenesis [ Time Frame: Baseline ]
    At the baseline assessment, de novo lipogenesis will be assessed by giving a high carbohydrate meal and heavy water to drink. Muscle glycogen and lipid contents pre- and post meal will be measured using 1H/13C MRS and de novo lipogenesis will be assessed from the heavy water incorporation into blood lipid in samples collected overnight.

  2. change in de novo lipogenesis [ Time Frame: 6 weeks ]
    At the 6 weeks assessment, de novo lipogenesis will be assessed by giving a high carbohydrate meal and heavy water to drink. Muscle glycogen and lipid contents pre- and post meal will be measured using 1H/13C MRS and de novo lipogenesis will be assessed from the heavy water incorporation into blood lipid in samples collected overnight.



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

Inclusion Criteria:

  • Body Mass Index < 29 kg/m2
  • No regular exercise routine
  • Non-smokers
  • Absence of systemic and organ disease.

Exclusion Criteria:

  • Hematocrit < 35 vol%
  • History of claustrophobia
  • Ferromagnetic implants
  • Regular exercise regimen
  • Not weight stable
  • Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
  • Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
  • Taking coumadin as anticoagulant therapy.

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): NCT02196051


Locations
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United States, Connecticut
YCCI/YNNH Hospital Research Unit
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kitt Petersen, MD Yale University
Publications of Results:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02196051    
Other Study ID Numbers: 0710003207
R56AG023686 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Insulin resistance
Exercise
de novo lipogenesis
NAFLD
Magnetic Resonance Spectroscopy
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases