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

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ClinicalTrials.gov Identifier: NCT01862757
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

May 23, 2013
May 24, 2013
July 2, 2017
May 6, 2013
June 14, 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01862757 on ClinicalTrials.gov Archive Site
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Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance
Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance

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.
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.
Observational
Time Perspective: Prospective
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Obesity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
15
March 13, 2015
June 14, 2013   (Final data collection date for primary outcome measure)
  • 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:

  • 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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01862757
130130
13-H-0130
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National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Richard O Cannon, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
March 13, 2015