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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05235867
Other study ID # IRB#21-001489
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source University of California, Los Angeles
Contact Misciel Macaraig
Phone 310-825-0922
Email mbmacaraig@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with restrictive-type anorexia nervosa who are admitted to the hospital for feeding often urinate excessive amounts. Others have changes in the way that they handle acid and base. These issues prolong hospitalizations. Current data suggest that one hormone--named secretin--may control both urine output and how the body handles acid and base. This study will evaluate whether secretin levels are different in anorexic patients who urinate an excessive amount compared to those who urinate normal amounts. For this study, patients will have one extra blood draw before and after one meal during their hospitalization. The blood draw before the meal coincides with a standard of care blood draw. Also after the meal, subjects will be asked to provide one extra urine sample. Information from subject's medical records will also be used.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 24 Years
Eligibility Inclusion Criteria: - Group 1: - male and female patients - age 13-24 years - diagnosis of restrictive-type anorexia nervosa - hospitalization for nutritional support - >4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5) - Group 2: - male and female patients - age 13-24 years - diagnosis of restrictive-type anorexia nervosa - hospitalization for nutritional support - <2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5) Exclusion Criteria: - 5150 hold - Anti-depressant, anti-psychotic, or anticonvulsant medications - Previous hospitalization within the past 6 months - Underlying metabolic disorder not related to anorexia nervosa (including chronic kidney disease, renal tubular disorders, and underlying endocrine disorders) - Pregnancy - NG or G-tube feeds after day 2 of hospitalization - > 10% of nutritional needs from supplemental feeds

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, Los Angeles (UCLA) Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in secretin Change in secretin value from pre- to post- meal 1 hour
Secondary Change in serum bicarbonate Change in bicarbonate value from pre- to post- meal 1 hour
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