NCT05235867

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Feb 2022Dec 2027

First Submitted

Initial submission to the registry

February 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

February 1, 2022

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in secretin

    Change in secretin value from pre- to post- meal

    1 hour

Secondary Outcomes (1)

  • Change in serum bicarbonate

    1 hour

Study Arms (2)

dumpers

* 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)

non-dumpers

* 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)

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with restrictive-type anorexia hospitalized for medical nutritional stabilization.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and urine

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 11, 2022

Study Start

February 1, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations