NCT01862757

Brief Summary

Background: \- Some people who are obese may have decreased muscle strength. They may have greater muscle mass shown in scans, but they show poor results in exercise tests. Poor muscle strength might cause some of the difficulty with exercise performance. Researchers want to test muscle strength in the arms and legs of overweight women. They will also see how insulin resistance affects muscle strength in these women. Objectives:

  • To test muscle strength in overweight women.
  • To see if insulin resistance affects muscle strength. Eligibility: \- Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2). Design:
  • Participants will be asked to fast before having an initial blood test to measure glucose and insulin levels.
  • On a different day, they will have the strength testing. The first test will measure leg muscle strength by testing the quadriceps and the hamstrings. The second test will measure arm muscle strength by testing the biceps and triceps. The final test will measure hand muscle (grip) strength.
  • All the tests should take about an hour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

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

May 6, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2015

Completed
Last Updated

July 2, 2017

Status Verified

March 13, 2015

Enrollment Period

1 month

First QC Date

May 23, 2013

Last Update Submit

June 30, 2017

Conditions

Obesity

Keywords

ObesityInsulinSkeletal MuscleStrength Testing

Outcome Measures

Primary Outcomes (1)

  • To determine whether increased extremity muscle mass associated with obesity, diminished insulin sensitivity and high insulin levels is associated with diminished strength.

    ongoing

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-diabetic female employees of NIH who participated in protocol 08-H-0108 and underwent insulin sensitivity testing and also protocol 02-H-0050 for muscle mass determination.
  • BP\< 140/90 mmHg (medications allowed)
  • Subject understands protocol and provides written, informed consent.

You may not qualify if:

  • Medical or surgical condition that would prohibit upper and lower extremity strength testing (e.g., painful arthritis, prior knee or elbow surgery)
  • Infection or injury to hand, knee or elbow requiring medical attention within 3 months of testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Leon B, Jenkins S, Pepin K, Chaudhry H, Smith K, Zalos G, Miller BV 3rd, Chen KY, Remaley AT, Waclawiw MA, Sumner AE, Cannon RO 3rd. Insulin and extremity muscle mass in overweight and obese women. Int J Obes (Lond). 2013 Dec;37(12):1560-4. doi: 10.1038/ijo.2013.45. Epub 2013 Mar 28.

    PMID: 23609936BACKGROUND

  • Park SW, Goodpaster BH, Strotmeyer ES, de Rekeneire N, Harris TB, Schwartz AV, Tylavsky FA, Newman AB. Decreased muscle strength and quality in older adults with type 2 diabetes: the health, aging, and body composition study. Diabetes. 2006 Jun;55(6):1813-8. doi: 10.2337/db05-1183.

    PMID: 16731847BACKGROUND

  • Kimball SR, Farrell PA, Jefferson LS. Invited Review: Role of insulin in translational control of protein synthesis in skeletal muscle by amino acids or exercise. J Appl Physiol (1985). 2002 Sep;93(3):1168-80. doi: 10.1152/japplphysiol.00221.2002.

    PMID: 12183515BACKGROUND

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Richard O Cannon, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 24, 2013

Study Start

May 6, 2013

Primary Completion

June 14, 2013

Study Completion

March 13, 2015

Last Updated

July 2, 2017

Record last verified: 2015-03-13

Locations

US(1)