Muscle OXPHOS and Nutrient Homeostasis (NCT02920671) | Clinical Trial Compass
CompletedNot Applicable
Muscle OXPHOS and Nutrient Homeostasis
United States45 participantsStarted 2017-02-14
Plain-language summary
Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive) without a family history of mitochondrial disease to compare to affected individuals.
The study involves non-invasive MRI methods and glucose tests to focus on the relationship between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures will be completed within 2 days, which includes an overnight stay at the Hospital of the University of Pennsylvania. There are no study medications or sedations, and participants will be continually monitored during minimally-invasive procedures (e.g., blood draws).
All participants will be able to receive compensation. Furthermore, it may be possible to provide reimbursement for travel, lodging, and meals for individuals with mitochondrial disease.
Investigators hope that this research will contribute to the current knowledge of mitochondrial disease and that it will improve diagnostic and treatment approaches.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female patients age 18 to 65 years of age.
✓. Ability to provide written informed consent.
✓. Cognitively and medically stable and able to comply with the procedures of the study protocol.
Exclusion criteria
✕. Diabetes (HgbA1c \> 6.4%) and/or taking insulin or other anti-diabetic drug therapy within the 4 weeks prior to enrollment.
✕. Use of any lipid-lowering medication (excluding nutritional supplements) within the 4 weeks prior to enrollment.
✕. Any contraindication to MRI study (e.g., implanted non-compatible device, pacemaker, known claustrophobia).
✕. Kidney disease. Estimated glomerular filtration rate \< 60 ml/min/1.73 m2 (calculated using the subject's measure serum creatinine and the Modification of Diet in Renal Disease \[MDRD\] study estimation formula).
✕. Liver disease. Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values \> 3 times normal upper limits, will exclude a subject from study participation.
What they're measuring
1
Glucose rate of disposal (glucose Rd) during OGTT*