Diet in the Management of Acromegaly

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05401084

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Other: Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of acromegaly.

Exclusion Criteria:

Diet restrictions.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Artak Labadzhyan, Assistant professor, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT05401084

Other Study ID Numbers:

STUDY00001851

First Posted:

Jun 2, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acromegaly

Study Results

No Results Posted as of Jul 20, 2022