Recruiting

Observational Study

Sponsor:

East Carolina University

Code:

NCT04320264

Conditions

Metabolic Inflexibility

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Weight loss surgery

Study Details

Brief summary:

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.

Conditions

Metabolic Inflexibility

Study ID

NCT04320264

Start date

Mar 3, 2020

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Low oxidizers/high lactate

Individuals with low aerobic oxidation

High oxidizers/low lactate

Individuals with high aerobic oxidation

Obese

Severely obese scheduled for surgery

Interventions

Weight loss surgery

Severely obese women (BMI >40) undergo sleeve gastrectomy

Primary outcome measure

  • Carbohydrate/fat oxidation (RER) in the fasting condition. [ Time Frame: Years 1-5 ]
  • Muscle oxygen consumption (substrate oxidation) in the fasting condition. [ Time Frame: Years 1-5 ]
  • Muscle lactate release in the fasting condition. [ Time Frame: Years 1-5 ]
  • Change in Carbohydrate/fat oxidation (RER) in response to glucose + insulin (metabolic flexibility) [ Time Frame: Years 1-5 ]
  • Change in muscle fat oxidation in response to high fat feeding (metabolic flexibility). [ Time Frame: Years 1-5 ]
  • Change in muscle oxygen consumption (substrate oxidation) in response to high fat feeding (metabolic flexibility). [ Time Frame: Years 1-5 ]

Central Contacts and Locations

Central contacts

Terry Jones, PhD

2527446249joneste@ecu.edu

Nicholas Broskey, PhD

2527374684broskeyn19@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Terry Jones, PhD

2527446249joneste@ecu.edu

Nicholas Broskey, PhD

2527374684broskeyn19@ecu.edu

More Information

Sponsor

East Carolina University

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • Metabolic Inflexibility
  • Obesity
  • Anaerobic glycolysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2025-08-07.