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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02043405

Enrollment

Registered

2014-01-23

Start date

2014-01-31

Completion date

2015-08-03

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Pre-diabetes

Brief summary

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

Interventions

BEHAVIORALWeight loss and exercise training intervention

Combined weight loss and exercise training intervention

BEHAVIORALWeight loss Only Intervention

Weight loss Only Intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026