Liver and Fat Regulation in Overweight Adolescent Girls (APPLE)
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ClinicalTrials.gov Identifier: NCT02157974 |
Recruitment Status :
Active, not recruiting
First Posted : June 6, 2014
Last Update Posted : August 11, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hepatic Steatosis Polycystic Ovarian Syndrome Obesity | Drug: Byetta 5Mcg Pen Injection | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls |
Actual Study Start Date : | August 2014 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Experimental: PCOS, medication naive + Byetta
PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.
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Drug: Byetta 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
Other Name: Exenatide |
No Intervention: Control
Up to 25 girls without PCOS
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No Intervention: PCOS medication naive
Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.
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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.
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No Intervention: PCOS on metformin
Up to 10 girls with PCOS and 6 months of therapy with metformin prior to study procedures
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- Hepatic glucose release [ Time Frame: Within 4 months from Screening Visit ]Hepatic glucose release will be measured by the rate of appearance of a glucose tracer.
- Hepatic phosphate concentrations [ Time Frame: Within 4 months from Screening Visit ]Hepatic phosphate relative concentrations will be measured with 31 phosphorus magnetic resonance spectroscopy
- Rates of lipolysis [ Time Frame: Within 4 months from Screening Visit ]Rate of lipolysis will be measured by the rate of appearance of a glycerol tracer.
- Hepatic steatosis [ Time Frame: Within 4 months from Screening Visit ]Determination of liver fat content via MRI
- Hepatic de novo lipogenesis [ Time Frame: Within 4 months from Screening Visit ]Hepatic de novo lipogenesis will be measured by with an acetate tracer.
- Whole Body Insulin Sensitivity [ Time Frame: Within 4 months from Screening Visit ]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.
- Sleep quality [ Time Frame: Within 4 months from Screening Visit ]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.
- Sleep duration [ Time Frame: Within 4 months from Screening Visit ]Sleep duration will be assessed using home actigraphy
- Microbiome [ Time Frame: Within 4 months from Screening Visit ]Stool microbiome profiling
- Amino Acid Metabolomics: glutamate [ Time Frame: Within 4 months from Screening Visit ]Targeted amino acid metabolomics will be performed to measure glutamate
- Lipid Metabolomics: 16n1 [ Time Frame: Within 4 months from Screening Visit ]Targeted lipid metabolomics will be performed to measure 16n1
- Bile Acid Metabolomics: sphingosine-1-phospate [ Time Frame: Within 4 months from Screening Visit ]Targeted bile acid metabolomics will be performed to measure sphingosine-1-phospate

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Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157974
United States, Colorado | |
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Melanie Cree Green, MD, PhD | Department of Endocrinology |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02157974 |
Other Study ID Numbers: |
14-0542 UL1TR001082 ( U.S. NIH Grant/Contract ) |
First Posted: | June 6, 2014 Key Record Dates |
Last Update Posted: | August 11, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data will only be shared with IRB approved personnel. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Polycystic Ovary Syndrome Fatty Liver Overweight Body Weight Liver Diseases Digestive System Diseases Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Gonadal Disorders Endocrine System Diseases Exenatide Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |