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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Pre-diabetes
• Intervention / Treatment: Behavioral: Weight loss and exercise training intervention; Behavioral: Weight loss Only Intervention

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity	Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in membrane localized diacylglycerol species	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.	baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Bryan Bergman, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 3, 2015
• Study Completion (Actual): August 3, 2015

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Hyperinsulinism; Body Weight Changes; Diabetes Mellitus; Weight Loss; Prediabetic State; Insulin Resistance
• Other Study ID Numbers: 13-1551; UL1TR001082 (U.S. NIH Grant/Contract)