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Hormone Level Management for Obesity

N/A
Waitlist Available
Led By Christine Burt Solorzano, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal and obese (>95th BMI%) females
Weight of 24 kg or more
Must not have
Weight<24 kg
History of Cushing's syndrome or adrenal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 hours (1900 - 0800 hrs)
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is studying how hormones develop in girls as they age, specifically looking at how weight affects hormone levels.

Who is the study for?
This trial is for girls aged 7-18 who are either at a normal weight or obese (above the 95th percentile for BMI), weighing at least 24 kg, and in any stage of puberty. They should have mostly normal lab results, though some hormone imbalances due to obesity are acceptable. Girls with severe anemia, abnormal morning cortisol levels, high 17-hydroxyprogesterone levels, underweight issues, pregnancy or history of specific adrenal gland disorders cannot participate.
What is being tested?
The study aims to understand the source of male and female hormones in growing girls by using Dexamethasone to suppress hormone production and Cortrosyn to stimulate it. This will help determine if overweight affects adrenal gland activity leading to higher hormone levels compared to non-overweight girls.
What are the potential side effects?
Dexamethasone may cause increased appetite, weight gain, trouble sleeping or mood swings. Cortrosyn might lead to flushing or feelings of warmth. Both drugs can potentially cause allergic reactions but these side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a female with a BMI in the normal range or above the 95th percentile.
Select...
I weigh at least 24 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I weigh less than 24 kg.
Select...
I have had Cushing's syndrome or adrenal insufficiency.
Select...
My lab results are not within the normal range for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 hours (1900 - 0800 hrs)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 hours (1900 - 0800 hrs) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
Secondary study objectives
Overnight changes in male and female hormones in response to ACTH suppression
Response to ACTH stimulation in normal weight and overweight girls

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dexamethasone, CortrosynExperimental Treatment2 Interventions
Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Tetracosactide
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,180 Previous Clinical Trials
1,574,972 Total Patients Enrolled
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,641 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,054 Previous Clinical Trials
2,731,550 Total Patients Enrolled

Media Library

Dexamethasone Clinical Trial Eligibility Overview. Trial Name: NCT01421797 — N/A
Androgen Syndrome Research Study Groups: Dexamethasone, Cortrosyn
Androgen Syndrome Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT01421797 — N/A
Dexamethasone 2023 Treatment Timeline for Medical Study. Trial Name: NCT01421797 — N/A
~4 spots leftby Nov 2025
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