NCT03041129: PLUM

Post-Prandial Liver Glucose Metabolism in PCOS

Completed Results posted Last updated 17 April 2024

What this trial tests

trial testing oral glucose tolerance test in Polycystic Ovarian Syndrome in 19 participants. Completed in 29 September 2018.

Timeline

14 April 2017

Primary endpoint
29 August 2018

29 September 2018

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Completed
Study type	OBSERVATIONAL
Enrollment	19
Start date	14 April 2017
Primary completion	29 August 2018
Estimated completion	29 September 2018
Sites	1 location across United States

Drugs / interventions tested

• oral glucose tolerance test — full drug profile →
• MRI of liver

Conditions studied

• Polycystic Ovarian Syndrome — all drugs for Polycystic Ovarian Syndrome →
• Obesity — all drugs for Obesity →
• Hepatic Steatosis — all drugs for Hepatic Steatosis →

Sponsor

University of Colorado, Denver

Who can join

Adults 12 to 21, female only, with Polycystic Ovarian Syndrome or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hepatic Fat Fraction Primary · Measured up to 4 months from enrollment

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.

Group	Value	95% CI
Untreated PCOS	8.35	± 7.55

Hepatic Metabolism Ratios Secondary · Measured up to 4 months from enrollment

Percent indirect glucose at 360 minutes following an oral sugar tolerance test (OGTT) with an isotope labeled oral glycerol tracer.

Group	Value	95% CI
Untreated PCOS	22.1	± 6.9

Whole Body Insulin Sensitivity Secondary · Measured up to 4 months from enrollment

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.

Group	Value	95% CI
Untreated PCOS	0.000278106	± 0.000393419

Sleep Duration Secondary · Measured up to 4 months from enrollment

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

Group	Value	95% CI
Untreated PCOS	443.44	± 52.63

Sleep Quality Secondary · Measured up to 4 months from enrollment

Apnea Hypopnea Index (AHI) will be measured using WatchPAT. 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

Group	Value	95% CI
Untreated PCOS	19.66	± 10.82

Hepatic Phosphate Concentrations Secondary · Measured up to 4 months from enrollment

31 phosphorus spectroscopy will be utilized to measure hepatic Phosphodiesterase (PDE)/Total phosphate concentration. This is measured in the MRI using a phosphorus coil.

Group	Value	95% CI
Untreated PCOS	23	± 7

Sponsor's own description

The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obese Adolescents With PCOS Have Altered Biodiversity and Relative Abundance in Gastrointestinal Microbiota.
   Jobira B, Frank DN, Pyle L, Silveira LJ, et al · · 2020 · cited 96× · PMID 31970418 · DOI 10.1210/clinem/dgz263
2. Poor Sleep Is Related to Metabolic Syndrome Severity in Adolescents With PCOS and Obesity.
   Simon S, Rahat H, Carreau AM, Garcia-Reyes Y, et al · · 2020 · cited 32× · PMID 31901092 · DOI 10.1210/clinem/dgz285
3. Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index).
   Carreau AM, Pyle L, Garcia-Reyes Y, Rahat H, et al · · 2019 · cited 24× · PMID 31301251 · DOI 10.1111/cen.14062
4. Hepatic steatosis relates to gastrointestinal microbiota changes in obese girls with polycystic ovary syndrome.
   Jobira B, Frank DN, Silveira LJ, Pyle L, et al · · 2021 · cited 19× · PMID 33465100 · DOI 10.1371/journal.pone.0245219
5. 11-Oxyandrogens in Adolescents With Polycystic Ovary Syndrome.
   Taylor AE, Ware MA, Breslow E, Pyle L, et al · · 2022 · cited 14× · PMID 35611324 · DOI 10.1210/jendso/bvac037
6. A simple method to monitor hepatic gluconeogenesis and triglyceride synthesis following oral sugar tolerance test in obese adolescents.
   Carreau AM, Jin ES, Garcia-Reyes Y, Rahat H, et al · · 2019 · cited 13× · PMID 31042400 · DOI 10.1152/ajpregu.00047.2019
7. Racial and Ethnic Differences in Metabolic Disease in Adolescents With Obesity and Polycystic Ovary Syndrome.
   Andrisse S, Garcia-Reyes Y, Pyle L, Kelsey MM, et al · · 2021 · cited 12× · PMID 33644620 · DOI 10.1210/jendso/bvab008
8. Oral minimal model-based estimates of insulin sensitivity in obese youth depend on oral glucose tolerance test protocol duration.
   Bartlette K, Carreau AM, Xie D, Garcia-Reyes Y, et al · · 2021 · cited 10× · PMID 33511337 · DOI 10.1016/j.metop.2021.100078