Diet in the Management of Acromegaly

September 19, 2023 updated by: Artak Labadzhyan, Cedars-Sinai Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Daniel Gomez
  • Phone Number: 424-315-4489

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Vivian Hwe
          • Phone Number: 424-315-4489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of acromegaly.

Exclusion Criteria:

  • Diet restrictions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbohydrate
Counseling, education, and implementation of low carbohydrate diet.
Other: Diet
Macronutrient diet changes.
Active Comparator: Low gluten
Counseling, education, and implementation of low gluten diet.
Other: Diet
Macronutrient diet changes.
No Intervention: Standard
No change/intervention in diet. Continuation of standard diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin-like growth factor 1 (IGF-1).
Time Frame: 8 weeks
Change in IGF-1 will be assessed from baseline (pre-intervention) to end of follow up.
8 weeks
Change in growth hormone level (GH).
Time Frame: 8 weeks
Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.
8 weeks
Change in acromegaly related symptoms.
Time Frame: 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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 28, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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