Clinical trial Recruiting at 1 site Observational Ages 18 to 50

Muscle energy use and its link to metabolic inflexibility

Official title: Metabolic Inflexibility is Related to Elevated Muscle Anaerobic Glycolysis

Run by East Carolina University · NCT04320264 · Data updated 2026-11-12

This study will test whether overweight adults (BMI 25–30) with higher fasting lactate rely more on anaerobic muscle metabolism and are more prone to metabolic inflexibility compared with low‑lactate overweight and severely obese participants.

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment100 (estimated)
SponsorEast Carolina University
Academic / other
Locations1 site (Greenville, North Carolina)
StatusRecruiting
StartedMarch 3, 2020
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedAugust 7, 2025
Trial IDNCT04320264 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18–50 who are overweight (BMI 25–30) able to attend metabolic testing and who fall into the top or bottom 25% of fasting lactate levels, with severely obese (BMI >40) patients enrolled as surgical comparators.

Probably not a fit

People with diabetes, heart disease, endocrine, hepatic, musculoskeletal or peripheral vascular disease, smokers, pregnant women, prisoners, mentally disabled individuals, or anyone taking medications that alter carbohydrate metabolism are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will recruit adults aged 18–50 who are overweight (BMI 25–30) and measure fasting plasma lactate to identify the top and bottom quartiles. High‑ and low‑lactate overweight participants will undergo in vivo muscle lactate release measurements and respiratory exchange ratio (RER) testing to characterize whole‑body substrate use and metabolic flexibility. Severely obese subjects (BMI >40) will be included as a comparator group and studied before and after gastric bypass to observe whether surgical weight loss shifts muscle metabolism. The project aims to link reliance on anaerobic glycolysis in muscle to shifts from fat to carbohydrate oxidation and to test whether changing muscle substrate preference can normalize metabolic flexibility.

Why it matters

Potential benefit: If successful, the findings could enable a simple blood test (fasting lactate) to identify non‑obese people at higher risk of obesity and target them for early prevention.

How similar studies have gone: Preliminary data and prior work indicate bariatric surgery can normalize muscle lactate and that lactate relates to metabolism, but using fasting lactate screening to predict obesity risk in non‑obese people is a relatively novel and unproven approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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
* 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

Where it's running

  • East Carolina University
    Greenville, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Joseph Houmard, PhD — East Carolina University
  • Study coordinator: Terry Jones, PhD
  • Email: joneste@ecu.edu
  • Phone: 2527446249

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.