CompletedNot Applicable

Hepatic Mitochondrial Function in Youth

United States20 participantsStarted 2018-11-20

Plain-language summary

Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth

Age range13 Years – 20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Obese youth ages 13-20 years, scheduled for bariatric surgery at Children's Hospital Colorado
✓. BMI 35-55 m2/kg
✓. Maximal body circumference \<200 cm

✕. Use of medications known to affect insulin sensitivity: oral glucocorticoids within 10; days, atypical antipsychotics, immunosuppressant agents, HIV medications.
✕. Infectious hepatitis
✕. Alcohol abuse
✕. Mitochondrial disease
✕. Type 2 diabetes
✕. Medications that affect hepatic outcomes (e.g. PPAR-γ or PPAR-α, metformin)
✕. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
✕. Severe illness requiring hospitalization within 60 days

Change in Percentage of Liver Fat Per MRI

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

Change in %Direct TG-Glycerol Appearance

Timeframe: Prior to bariatric surgery and 1 year post-bariatric surgery

NCT IDNCT03587727

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-21

Results submitted2024-06-03