Clinical trial NCT02157974: Liver and Fat Regulation in Overweight Adolescent Girls
Official title: Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatic Steatosis
Polycystic Ovarian Syndrome
Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-06
Enrollment: 92
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures.

Detailed description: Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be collected fasting and after a glucose challenge. The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).

Eligibility criteria: Inclusion Criteria:

* Females
* 2 years post-menarche
* BMI percentile \>90%

Exclusion Criteria:

* Type 2 diabetes
* Anemia
* Liver disease
* Medications known to effect insulin sensitivity
* Cause of oligomenorrhea or hirsutism other than PCOS,
* \>3 hours a week of moderate exercise.

Primary outcomes:
measure: Hepatic Glucose Release
timeFrame: Measured up to 4 months from enrollment
Secondary outcomes:
measure: Hepatic Phosphate Concentrations
timeFrame: Measured up to 4 months from enrollment
measure: Rates of Lipolysis
timeFrame: Measured up to 4 months from enrollment
measure: Hepatic Fat Fraction
timeFrame: Measured up to 4 months from enrollment
measure: Hepatic de Novo Lipogenesis
timeFrame: Measured up to 4 months from enrollment
Other outcomes:
measure: Whole Body Insulin Sensitivity
timeFrame: Measured up to 4 months from enrollment
measure: Sleep Quality
timeFrame: Measured up to 4 months from enrollment
measure: Sleep Duration
timeFrame: Measured up to 4 months from enrollment
Locations:
city: Aurora
country: United States
facility: University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Department of Endocrinology
name: Melanie Cree Green, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carreau AM, Pyle L, Garcia-Reyes Y, Rahat H, Vigers T, Jensen T, Scherzinger A, Nadeau KJ, Cree-Green M. Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index). Clin Endocrinol (Oxf). 2019 Oct;91(4):544-552. doi: 10.1111/cen.14062. Epub 2019 Aug 16.
citation: Simon SL, McWhirter L, Diniz Behn C, Bubar KM, Kaar JL, Pyle L, Rahat H, Garcia-Reyes Y, Carreau AM, Wright KP, Nadeau KJ, Cree-Green M. Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3525-3534. doi: 10.1210/jc.2018-02385.