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NCT05401084 Clinical Trial

Diet in the Management of Acromegaly

Acromegaly Clinical Trial

Official title:
Impact of Low Carbohydrate and Low Gluten Diet on Acromegaly Progression, Symptoms, Complications, and Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05401084
Other study ID # STUDY00001851
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2024
Est. completion date March 1, 2025

Study information
Verified date April 2024
Source Cedars-Sinai Medical Center
Contact Vivian Hwe
Phone 424-315-4489
Email Vivian.Hwe@cshs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 9
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of acromegaly. Exclusion Criteria: - Diet restrictions.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Diet
Macronutrient diet changes.

Locations
Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in insulin-like growth factor 1 (IGF-1). Change in IGF-1 will be assessed from baseline (pre-intervention) to end of follow up. 8 weeks
Primary Change in growth hormone level (GH). Change in GH level will be assessed from baseline (pre-intervention) to end of follow up. 8 weeks
Primary Change in acromegaly related symptoms. Change in acromegaly related symptoms will be assessed from baseline (pre-intervention) to end of follow up using Acromegaly Quality of Life Questionnaire (AcroQoL). 8 weeks
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