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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
Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 hours (1900 - 0800 hrs)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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My blood tests are mostly normal, though I might have slight changes due to being overweight.
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I am between 7 and 18 years old, experiencing puberty.
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I weigh at least 24 kg.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,760 Total Patients Enrolled
University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,919 Total Patients Enrolled
University of California, San DiegoOTHER
1,114 Previous Clinical Trials
1,519,796 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this trial accommodating participants?

"Affirmative, this clinical trial is actively recruiting subjects- according to the data hosted on clinicaltrials.gov, it was first listed on October 10th 2006 and recently updated July 28th 2022; 84 patients are needed across a single site."

Answered by AI

Could you please elucidate the results of prior experiments involving Dexamethasone?

"Currently, 555 clinical trials are being conducted in order to assess the efficacy of Dexamethasone. Of these studies, 143 have progressed to Phase 3 and a total of 18656 locations across America are taking part in this research. The epicentre for this investigation is Elk Grove Village, Illinois."

Answered by AI

Does the current research protocol permit enrolment of individuals over 30 years old?

"Patients aged 7 to 18 years old are eligible for inclusion in this study."

Answered by AI

What medical conditions can Dexamethasone be prescribed to alleviate?

"Dexamethasone is widely used to treat synovitis, though it can also be administered for ophthalmia and branch retinal vein occlusion-related macular edema."

Answered by AI

Are there still openings in this trial for participants?

"According to the records available on clinicaltrials.gov, this study is currently accepting candidates. The initial posting of information was made on October 10th 2006 and it has since been updated as recently as July 28th 2022."

Answered by AI

To whom is this clinical trial open?

"This trial seeks to include 84 participants who have sclerocystic ovaries and are between 7-18 years old."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
University of Virginia Center for Research in Reproduction
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~2 spots leftby Aug 2024