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

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)

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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