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Liver and Fat Regulation in Overweight Adolescent Girls (APPLE Trial)

Phase 2 & 3
Waitlist Available
Led By Melanie Cree Green, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured up to 4 months from enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial studies overweight, sedentary girls with or without PCOS to understand why women with PCOS have more liver fat. Researchers will use special blood markers to see how their bodies handle sugar and fat. They will also use imaging to look at liver and body fat.

Eligible Conditions
  • Obesity
  • Polycystic Ovarian Syndrome
  • Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured up to 4 months from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured up to 4 months from enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hepatic Glucose Release
Secondary study objectives
Hepatic Fat Fraction
Hepatic Phosphate Concentrations
Hepatic de Novo Lipogenesis
+1 more
Other study objectives
Sleep Duration
Sleep Quality
Whole Body Insulin Sensitivity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: PCOS, medication naive + ByettaExperimental Treatment1 Intervention
PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.
Group II: PCOS on metforminActive Control1 Intervention
Up to 10 girls with PCOS and 6 months of therapy with metformin prior to study procedures
Group III: ControlActive Control1 Intervention
Up to 25 girls without PCOS
Group IV: PCOS on COCPsActive Control1 Intervention
Up to 10 girls with PCOS and 6 months of therapy with combined oral contraceptives (COCPs) prior to study procedures.
Group V: PCOS medication naiveActive Control1 Intervention
Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Byetta 5Mcg Pen Injection
2014
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,016 Total Patients Enrolled
469 Trials studying Obesity
589,922 Patients Enrolled for Obesity
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,207 Total Patients Enrolled
106 Trials studying Obesity
214,395 Patients Enrolled for Obesity
National Center for Advancing Translational Sciences (NCATS)NIH
374 Previous Clinical Trials
409,190 Total Patients Enrolled
15 Trials studying Obesity
4,380 Patients Enrolled for Obesity
Melanie Cree Green, MD, PhDPrincipal InvestigatorDepartment of Endocrinology
~8 spots leftby Dec 2025
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