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

Not Applicable

Completed

• Conditions: Pre-diabetes; Diabetes
• Interventions: Behavioral: Weight loss Only Intervention; Behavioral: Weight loss and exercise training intervention

• Registration Number: NCT02043405
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2015-08-03
• Study Completion: 2015-08-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	baseline and 3 months	Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention

Secondary Outcome Measures

Name	Time	Method
Change in membrane localized diacylglycerol species	baseline and 3 months	Change in concentration of membrane and cytosolic diacylglycerol species before and after the intervention. Diacylglycerol is a lipid known to be related to insulin resistance.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States