Diet in the Management of Acromegaly

Not Applicable

Recruiting

• Conditions: Acromegaly
• Interventions: Other: Diet

• Registration Number: NCT05401084
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-28
• Study First Posted: 2022-06-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Study Start: 2024-09-20
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Diagnosis of acromegaly.

Exclusion Criteria

• Diet restrictions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low gluten	Diet	Counseling, education, and implementation of low gluten diet.
Carbohydrate	Diet	Counseling, education, and implementation of low carbohydrate diet.

Primary Outcome Measures

Name	Time	Method
Change in acromegaly related symptoms.	8 weeks	Change in acromegaly related symptoms will be assessed from baseline (pre-intervention) to end of follow up using Acromegaly Quality of Life Questionnaire (AcroQoL).
Change in growth hormone level (GH).	8 weeks	Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.
Change in insulin-like growth factor 1 (IGF-1).	8 weeks	Change in IGF-1 will be assessed from baseline (pre-intervention) to end of follow up.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States