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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01862757
First received: May 23, 2013
Last updated: April 16, 2014
Last verified: March 2014
  Purpose

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.

Condition
Obesity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: May 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862757

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Richard O Cannon, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01862757     History of Changes
Other Study ID Numbers: 130130, 13-H-0130
Study First Received: May 23, 2013
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Obesity
Insulin
Skeletal Muscle
Strength Testing

Additional relevant MeSH terms:
Obesity
Overweight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014