Recruiting

Diet

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05401084

Conditions

Acromegaly

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet

Study Details

Brief summary:

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

Conditions

Acromegaly

Study ID

NCT05401084

Start date

Sep 20, 2024

Status verified date

Apr, 2024

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of acromegaly.

Exclusion Criteria:

  • Diet restrictions.

Study Design

Enrollment

9 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Carbohydrate

Counseling, education, and implementation of low carbohydrate diet.

active comparator: Low gluten

Counseling, education, and implementation of low gluten diet.

no intervention: Standard

No change/intervention in diet. Continuation of standard diet.

Interventions

Diet

Macronutrient diet changes.

Primary outcome measure

  • Change in insulin-like growth factor 1 (IGF-1). [ Time Frame: 8 weeks ]
  • Change in growth hormone level (GH). [ Time Frame: 8 weeks ]
  • Change in acromegaly related symptoms. [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Vivian Hwe

424-315-4489Vivian.Hwe@cshs.org

Daniel Gomez

424-315-4489

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Vivian Hwe

424-315-4489

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Apr 19, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2024-04-19.