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Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Diabetes
Pre-diabetes

Treatments

Behavioral: Weight loss and exercise training intervention
Behavioral: Weight loss Only Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02043405
13-1551
UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.

Enrollment

21 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)

  • Ages ranging from 30-60 years old;

  • Individuals with:

    • impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (<140 mg/dl 2 hrs after 75g OGTT)
    • impaired glucose tolerance (IGT), (normal fasting glucose <100mg/dl, with post-prandial glucose (>140 mg/dl 2 hrs after 75g OGTT)
    • a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and
  • Sedentary (<2 hours/week of planned physical activity).

To increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.

Exclusion criteria

  • Regular exercise more than 2 hours/week,
  • medications that could affect glucose,
  • lipid metabolism,
  • thyroid disease,
  • history of lung disease,
  • pregnancy,
  • active cigarette smoking or exposure to second hand smoke, and
  • Severe plasma lipid disorders.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Exercise Training and Weight Loss Intervention
Experimental group
Description:
Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle.
Treatment:
Behavioral: Weight loss and exercise training intervention
4 Month Weight Loss Only Intervention
Active Comparator group
Description:
Use exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes.
Treatment:
Behavioral: Weight loss Only Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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