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CompletedNCT01862757Updated Jul 2, 2017

Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance

An observational study in Obesity, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
13
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.
Read the detailed description

We have observed in our protocol (08-H-0108: Effects of Worksite Wellness Interventions on Vascular Function, Insulin Sensitivity and High-Density Lipoprotein in Overweight or Obese Women) that despite increased lean (muscle) mass in the extremities as measured by dual x-ray absorptiometry, obese women have poorer exercise tolerance than overweight women who have less muscle mass.1 Exercise testing, however, is an integrated function of cardiopulmonary capacity, in addition to muscle strength and endurance. We propose to determine whether muscle strength of elbow flexors and knee extensor muscle groups correlates with muscle mass of these groups in overweight and obese women selected for normal or abnormal insulin sensitivity. Our hypothesis is that subjects with impaired insulin sensitivity and high insulin levels will have greater muscle mass but lower muscle strength than subjects with normal insulin sensitivity and normal insulin levels. This is a feasibility study to be conducted in 10 non-diabetic women (5 with insulin resistance, 5 with normal insulin sensitivity) who previously participated in 08-H-0108, the outcome of which will provide data for planning a larger study of muscle mass and strength which may be important to achieving exercise goals important to successful weight loss.

02

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Insulin
  • Skeletal Muscle
  • Strength Testing
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 13 is below the median of 150 across 436 observational studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

EXCLUSION CRITERIA:

  • 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
05

Study design

Time perspective
Prospective
Enrollment
13 participants (actual)
06

What researchers measure

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.

    Time frame: ongoing

07

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • 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. PubMed 23609936 ↗
  • 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. PubMed 16731847 ↗
  • 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. PubMed 12183515 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01862757
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
May 24, 2013
Start date
May 6, 2013
Primary completion
Jun 14, 2013
Completion
Mar 13, 2015
Last update
Jul 2, 2017

Study contacts

Richard O Cannon, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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