NCT04320264 · East Carolina University
Metabolic Inflexibility is Related to Elevated Muscle Anaerobic Glycolysis
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Weight loss surgery
Severely obese women (BMI \>40) undergo sleeve gastrectomy
Primary outcome measures
Carbohydrate/fat oxidation (RER) in the fasting condition.
Time frame: Years 1-5
RER will be measured from indirect calorimetry
Muscle oxygen consumption (substrate oxidation) in the fasting condition.
Time frame: Years 1-5
Muscle oxygen consumption will be measured by near-infrared spectroscopy (NIRS)
Muscle lactate release in the fasting condition.
Time frame: Years 1-5
Muscle lactate release will be measured by microdialysis
Change in Carbohydrate/fat oxidation (RER) in response to glucose + insulin (metabolic flexibility)
Time frame: Years 1-5
Indirect calorimetry during glucose clamp
Change in muscle fat oxidation in response to high fat feeding (metabolic flexibility).
Time frame: Years 1-5
Oxidation of fatty acid in muscle homogenate.
Change in muscle oxygen consumption (substrate oxidation) in response to high fat feeding (metabolic flexibility).
Time frame: Years 1-5
Oxygen consumption measured by near-infrared spectroscopy (NIRS)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-50 years old
- BMI of 25 - 30 kg/m2
- BMI \> 40kg/m2
- Lactate levels in top and lower 25%
Exclusion criteria
- Pregnant women
- Mentally disabled
- Subjects with heart disease
- Type 1 and 2 diabetes
- Endocrine disease
- Hypertension
- Musculoskeletal disease
- Peripheral occlusion
- Hepatic disease
- Have had weight fluctuations exceeding + 3% in the previous 12 months
- On medications which alter carbohydrate metabolism will not be studied
Where
- Greenville, North Carolina
Collaborators
Duke University, University of Arkansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2025 · Source of record for eligibility and locations