Status:
RECRUITING
Metabolic Diet for Relapse Prevention in Anorexia Nervosa
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This is an interventional study that will test the safety, tolerability, and efficacy of the Metabolic Diet, which was designed as a treatment for women with anorexia nervosa to remain weight-stable a...
Detailed Description
The study plan to enroll a total of 20 subjects from the broader New York City area into an 8-week eating behavioral program. Of the 20, 10 will be weight-restored patients with anorexia nervosa (WR-A...
Eligibility Criteria
Inclusion
- Female
- Age at least 18 and not over 40
- BMI at or above 18.5 kg/m2
- Speaks English
- Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws
- History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only)
- Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only)
Exclusion
- Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders
- Active DSM-5 substance use disorders
- On medications that could affect metabolism
- \*Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing.
- History of suicide attempt within previous 6 months or acute suicide risk
- Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy
- Current/lifetime diagnosis of DSM-5 eating disorders (HC only)
- Active DSM-5 depressive disorders (HC only)
Key Trial Info
Start Date :
November 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05197309
Start Date
November 20 2022
End Date
December 1 2026
Last Update
February 4 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029