NCT06896682

Brief Summary

The goal of this observational study is to learn about how bariatric surgery affects the metabolism of cortisol. The main question it aims to answer is whether changes in cortisol contribute to the development of reactive hypoglycemia? 100 individuals who have previously undergone bariatric surgery, are planned to be included.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jul 2025

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

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Study Timeline

Key milestones and dates

Study Progress56%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

March 3, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 3, 2025

Last Update Submit

March 11, 2026

Conditions

Postbariatric Hypoglycemia

Keywords

cortisolbariatric surgerypostbariatric hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Changes in serum cortisol during mixed meal test

    cortisol at nadir glucose during the mixed meal test - cortisol at the start of the meal test

    0, 30, 60, 90, 120, 150, 180 minutes (visit 2)

Secondary Outcomes (3)

  • ACTH test: Test of adrenal function

    0, 30 minutes

  • Cortisol hormone profile

    1 hour

  • urinary cortisol: Ratio of cortisol/cortisone

    24 hour

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

postbariatric patients

You may qualify if:

  • Participants must have undergone one of the following bariatric procedures at least 12 months prior:
  • Roux-en-Y gastric bypass
  • Gastric sleeve

You may not qualify if:

  • Pregnancy and breastfeeding
  • Nephrotic syndrome (kidney disease with protein loss in urine), liver cirrhosis, or severe malnutrition, as these conditions reduce cortisol-binding globulin (CBG) levels, affecting total cortisol concentration
  • Use of corticosteroid medications, such as prednisolone
  • Use of opiod-containing medication
  • Use of medications containing estrogen, such as hormone therapy for menopause
  • Known adrenal disease affecting cortisol metabolism, including autonomous cortisol production and Cushing's syndrome
  • Diabetes that does not require medical treatment
  • Previously diagnosed reactive hypoglycemia after bariatric surgery requiring medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esbjerg Hospital

Esbjerg, 6700, Denmark

RECRUITING

Central Study Contacts

Charlotte R Stolberg, MD PhD

CONTACT

+4579183127charlotte.ron.stolberg@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Senior Registrar in Endocrinology

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 26, 2025

Study Start

July 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 13, 2026

Record last verified: 2025-03

Locations

DK(1)