NCT00786578

Brief Summary

Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

4 years

First QC Date

November 5, 2008

Last Update Submit

October 23, 2014

Conditions

Keywords

trainingintramyocellular lipidinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • absolute change in intramyocellular lipid quantity with exercise

    over 4 months

Study Arms (2)

1

overweight runners (BMI\>25)

2

lean runners (BMI\<24)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects on regular running program.

You may qualify if:

  • Age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type.
  • We will define the lean trained group by a BMI of \< 24 kg/m2. We will define the overweight group as BMI \> 26 25 kg/m2.
  • The subjects should be participating in regular running exercise (\> 30 min/day, ≥ 5 days/week).
  • Weight must be stable \[+/- 5 pounds\] for at least the three months prior to the study for all participants.

You may not qualify if:

  • The subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills, or diuretics.
  • The subjects should not be on a high fat diet (\> 45% fat) as measured by a screening questionnaire.
  • The subject must not have any contraindications to magnetic resonance imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeresity of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood will be sampled and retained for future metabolic testing as needed

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lisa S Chow

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations