Back to resultsWeight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
Primary Purpose
Diabetes, Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss and exercise training intervention
Weight loss Only Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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.
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Training and Weight Loss Intervention
4 Month Weight Loss Only Intervention
Arm Description
Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle.
Use exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes.
Outcomes
Primary Outcome Measures
Change in insulin sensitivity
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
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.
Full Information
NCT ID
NCT02043405
First Posted
January 16, 2014
Last Updated
April 21, 2022
Sponsor
University of Colorado, Denver
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT02043405
Brief Title
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
Official Title
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 3, 2015 (Actual)
Study Completion Date
August 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre-diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training and Weight Loss Intervention
Arm Type
Experimental
Arm Description
Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle.
Arm Title
4 Month Weight Loss Only Intervention
Arm Type
Active Comparator
Arm Description
Use exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss and exercise training intervention
Intervention Description
Combined weight loss and exercise training intervention
Intervention Type
Behavioral
Intervention Name(s)
Weight loss Only Intervention
Intervention Description
Weight loss Only Intervention
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in membrane localized diacylglycerol species
Description
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.
Time Frame
baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Bergman, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
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