Health TrialsbyHealthPanel

Metabolic Inflexibility is Related to Elevated Muscle Anaerobic Glycolysis

ConditionMetabolic Inflexibility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorEast Carolina University

About this trial

The focus of this proposal is on overweight (25\>BMI\<30 kg/m2) subjects, as these individuals exhibit a high risk of becoming obese and/or developing metabolic diseases. We hypothesize that in some overweight individuals there is a "metabolic program" in skeletal muscle which predisposes them to the development of obesity. Findings may lead to clinical screening tools for determining risk for obesity in non-obese individuals and targeting this group for prevention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-50 years old

BMI of 25 - 30 kg/m2

BMI > 40kg/m2

Lactate levels in top and lower 25%

Disqualifiers

Pregnant women

Mentally disabled

Prisoners

Smokers

Trial population

High oxidizers Low oxidizers Obese

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Weight loss surgery

    Procedure/Surgery

    Severely obese women (BMI \>40) undergo sleeve gastrectomy

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Low oxidizers/high lactate0 interventions
Group B: High oxidizers/low lactate0 interventions
Group C: Obese1 intervention

Trial outcomes

Primary outcomes

1

Carbohydrate/fat oxidation (RER) in the fasting condition.

RER will be measured from indirect calorimetry

Time frame
Years 1-5
2

Muscle oxygen consumption (substrate oxidation) in the fasting condition.

Muscle oxygen consumption will be measured by near-infrared spectroscopy (NIRS)

Time frame
Years 1-5
3

Muscle lactate release in the fasting condition.

Muscle lactate release will be measured by microdialysis

Time frame
Years 1-5
4

Change in Carbohydrate/fat oxidation (RER) in response to glucose + insulin (metabolic flexibility)

Indirect calorimetry during glucose clamp

Time frame
Years 1-5

Secondary outcomes

1

Insulin sensitivity (clamp M value).

Measured during glucose clamp.

Time frame
Years 1-5
2

Endogenous glucose production in the fasting condition.

Measured with isotopically labeled glucose

Time frame
Years 1-5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

East Carolina University

Lead sponsor

Duke University

Collaborator

University of Arkansas

Collaborator

Source ClinicalTrials.gov
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