Liver and Fat Regulation in Overweight Adolescent Girls

Browse trials for

• Polycystic Ovary Syndrome 944
• Fatty Liver 1,451
• Overweight 3,670

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 92 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Study arms

• Experimental
  PCOS, medication naive + Byetta

  PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.

  Drug: Byetta 5Mcg Pen Injection

• No intervention
  Control

  Up to 25 girls without PCOS

• No intervention
  PCOS medication naive

  Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.

• No intervention
  PCOS on COCPs

  Up to 10 girls with PCOS and 6 months of therapy with combined oral contraceptives (COCPs) prior to study procedures.

• No intervention
  PCOS on metformin

  Up to 10 girls with PCOS and 6 months of therapy with metformin prior to study procedures

Interventions

• DrugByetta 5Mcg Pen Injection

  10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola

  Also known as: Exenatide

Primary outcomes

1. Hepatic Glucose Release

   Hepatic glucose release will be measured by the rate of appearance of a glucose tracer. Glucose rate of appearance reflects the amount of glucose being release by primarily the liver during fasting. A higher glucose rate of appearance is often seen with dysglycemia

   Time frame: Measured up to 4 months from enrollment

Secondary outcomes

1. Hepatic Phosphate Concentrations

   Hepatic phosphate relative concentrations will be measured with 31 phosphorus magnetic resonance spectroscopy. The ratio of the following will be reported over total phosphate concentration: Phosphodiesterase (PDE), phosphomonoester (PME), Adenosine triphosphate (ATP), Inorganic Phosphate (Pi),Nicotinamide adenine dinucleotide phosphate (NADPH), Uridine diphosphate glucose (UDPG)

   Time frame: Measured up to 4 months from enrollment

2. Rates of Lipolysis

   Rate of lipolysis will be measured by the rate of appearance of a glycerol tracer. Glycerol rate of appearance reflects the amount of glycerol being released into the blood stream as a results of lipolysis. Higher rates of lipolysis are thought to be associated with insulin resistance.

   Time frame: Measured up to 4 months from enrollment

3. Hepatic Fat Fraction

   Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.

   Time frame: Measured up to 4 months from enrollment

4. Hepatic de Novo Lipogenesis

   Hepatic de novo lipogenesis will be measured by with an acetate tracer by mass spectroscopy. De novo lipogenesis can contribute to non-alcoholic fatty liver disease, so having a lower value is better.

   Time frame: Measured up to 4 months from enrollment

Other outcomes

1. Whole Body Insulin Sensitivity

   Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model using SAMM II software. This software uses participant weight, glucose and insulin concentrations at various time points during the oral glucose tolerance test to calculate the participant insulin sensitivity. The higher the Si value means more insulin sensitivity.

   Time frame: Measured up to 4 months from enrollment

2. Sleep Quality

   Apnea Hypopnea Index (AHI) will be measured using WatchPAT. In children and adolescents the scale that will be used is AHI\>5 is considered mild sleep apnea. The higher the AHI, indicates more severe sleep apnea. The AHI is the number of times you have apnea or hypopnea during one night, divided by the hours of sleep. Normal sleep: An AHI of fewer than five events, on average, per hour Mild sleep apnea: An AHI of five to 14 events per hour Moderate sleep apnea: An AHI of 15 to 29 events per hour Severe sleep apnea: An AHI of 30 or more events per hour

   Time frame: Measured up to 4 months from enrollment

3. Sleep Duration

   Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data.

   Time frame: Measured up to 4 months from enrollment

Baseline characteristics

Publications

• 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. PubMed 31301251 ↗
• 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. PubMed 30888398 ↗

Study documents

• Protocol and statistical analysis plan · Nov 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data will only be shared with IRB approved personnel.