Liver and Fat Regulation in Overweight Adolescent Girls

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Hepatic Steatosis Polycystic Ovarian Syndrome Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PCOS, medication naive + Byetta

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

Group Type EXPERIMENTAL

Byetta 5Mcg Pen Injection

Intervention Type DRUG

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

Control

Up to 25 girls without PCOS

Group Type NO_INTERVENTION

No interventions assigned to this group

PCOS medication naive

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

Group Type NO_INTERVENTION

No interventions assigned to this group

PCOS on COCPs

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

Group Type NO_INTERVENTION

No interventions assigned to this group

PCOS on metformin

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Exenatide

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes