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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043405
• Other study ID #: 13-1551
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 3, 2015

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 3, 2015
• Est. primary completion date: August 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Insulin Resistance
• Pre-diabetes
• Prediabetic State
• Weight Loss

Intervention

Behavioral:
• Weight loss and exercise training intervention
Combined weight loss and exercise training intervention
• Weight loss Only Intervention
Weight loss Only Intervention

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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