NCT02196051

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

4.1 years

First QC Date

June 25, 2014

Last Update Submit

August 12, 2024

Conditions

Insulin Resistance

Keywords

Insulin resistanceExercisede novo lipogenesisNAFLDMagnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • change in de novo lipogenesis

    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

Study Arms (1)

Exercise Training

EXPERIMENTAL

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

Interventions

one bout of 45 minutes exerciseOTHER

45 minutes of exercise on an elliptical exercise machine

Exercise Training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YCCI/YNNH Hospital Research Unit

New Haven, Connecticut, 06520, United States

Location

Related Publications (2)

  • Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.

    PMID: 21808028RESULT

  • Flannery C, Dufour S, Rabol R, Shulman GI, Petersen KF. Skeletal muscle insulin resistance promotes increased hepatic de novo lipogenesis, hyperlipidemia, and hepatic steatosis in the elderly. Diabetes. 2012 Nov;61(11):2711-7. doi: 10.2337/db12-0206. Epub 2012 Jul 24.

    PMID: 22829450RESULT

MeSH Terms

Conditions

Insulin ResistanceMotor ActivityNon-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kitt Petersen, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 21, 2014

Study Start

January 1, 2008

Primary Completion

January 30, 2012

Study Completion

January 30, 2012

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)