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

August 12, 2024 updated by: Yale University

Lipid and Carbohydrate Metabolism: Effects of Exercise

The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.

The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • YCCI/YNNH Hospital Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Training
Participants engaged in a single bout of elliptical exercise for 45 minutes (3 times 15 minutes spaced by 5 minutes rest) at baseline. Subjects will be studied before and after this one bout to measure hepatic de novo lipogenesis. Hepatic de novo lipogenesis will be compared pre and post to examine whether acutely 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: one bout of 45 minutes exercise
45 minutes of exercise on an elliptical exercise machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in de novo lipogenesis
Time Frame: Baseline
At the baseline assessment, de novo lipogenesis was assessed after a high carbohydrate meal and a drink of heavy water. Muscle glycogen and lipid contents were measured pre- and post meal using 1H/13C MRS and de novo lipogenesis was assessed from the heavy water incorporation into blood lipid in samples collected overnight.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kitt Petersen, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 30, 2012

Study Completion (Actual)

January 30, 2012

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimated)

July 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0710003207
  • R56AG023686 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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