Observational Study on Metabolic Inflexibility and Obesity Risk

This observational study is looking at how your body uses energy (metabolism) and its connection to metabolic inflexibility, which might increase the risk of obesity. Researchers believe that some overweight individuals might have a "metabolic program" in their muscles that makes them more likely to become obese. They are studying overweight individuals (BMI 25-30 kg/m2) and severely obese women (BMI >40 kg/m2) who are undergoing weight loss surgery (sleeve gastrectomy). The study will measure how your body burns carbohydrates and fats, and how your muscles use oxygen and release lactate (a chemical produced when your body breaks down sugar for energy). The goal is to understand if relying more on sugar for energy in your muscles leads to metabolic inflexibility and obesity. This study is currently recruiting participants aged 18 to 50 years old.

Study design
This is an observational study planning to enroll 100 participants. It compares overweight individuals with different lactate levels and severely obese individuals.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for measurements over 1 to 5 years.

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NCT04320264

Metabolic Inflexibility is Related to Elevated Muscle Anaerobic Glycolysis

Recruiting
Not specifiedAges 18–50Observational
East Carolina University
~100 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:Weight loss surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Carbohydrate/fat oxidation (RER) in the fasting condition.
Measured over Years 1-5
+5 more outcomes measured
Metabolic Inflexibility
1 sites across 1 states
North Carolina1
  • Joseph Houmard, PhD · PRINCIPAL_INVESTIGATOR · East Carolina University

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Eligibility criteria

Inclusion

18-50 years old
BMI of 25 - 30 kg/m2
BMI \> 40kg/m2
Lactate levels in top and lower 25%

Exclusion

Pregnant women
Mentally disabled
Prisoners
Smokers
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
  • Carbohydrate/fat oxidation (RER) in the fasting condition.Years 1-5

    RER will be measured from indirect calorimetry

  • Muscle oxygen consumption (substrate oxidation) in the fasting condition.Years 1-5

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

  • Muscle lactate release in the fasting condition.Years 1-5

    Muscle lactate release will be measured by microdialysis

  • Change in Carbohydrate/fat oxidation (RER) in response to glucose + insulin (metabolic flexibility)Years 1-5

    Indirect calorimetry during glucose clamp

  • Change in muscle fat oxidation in response to high fat feeding (metabolic flexibility).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).Years 1-5

    Oxygen consumption measured by near-infrared spectroscopy (NIRS)