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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02043405

Collaborator

American Diabetes Association (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Pre-diabetes	Behavioral: Weight loss and exercise training intervention Behavioral: Weight loss Only Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Aug 3, 2015

Actual Study Completion Date :

Aug 3, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
American Diabetes Association

Investigators

Principal Investigator: Bryan Bergman, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02043405

Other Study ID Numbers:

13-1551
UL1TR001082

First Posted:

Jan 23, 2014

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022