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Diet in the Management of Acromegaly

Primary Purpose

Acromegaly

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of acromegaly.

Exclusion Criteria:

Diet restrictions.

Sites / Locations

Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Carbohydrate

Low gluten

Standard

Arm Description

Counseling, education, and implementation of low carbohydrate diet.

Counseling, education, and implementation of low gluten diet.

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

Outcomes

Primary Outcome Measures

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.

Change in growth hormone level (GH).

Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05401084

First Posted

May 23, 2022

Last Updated

September 19, 2023

Sponsor

Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05401084

Brief Title

Diet in the Management of Acromegaly

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2023 (Anticipated)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carbohydrate

Arm Type

Active Comparator

Arm Description

Counseling, education, and implementation of low carbohydrate diet.

Arm Title

Low gluten

Arm Type

Active Comparator

Arm Description

Counseling, education, and implementation of low gluten diet.

Arm Title

Standard

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

Macronutrient diet changes.

Primary Outcome Measure Information:

Title

Change in insulin-like growth factor 1 (IGF-1).

Description

Change in IGF-1 will be assessed from baseline (pre-intervention) to end of follow up.

Time Frame

8 weeks

Title

Change in growth hormone level (GH).

Description

Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.

Time Frame

8 weeks

Title

Change in acromegaly related symptoms.

Description

Change in acromegaly related symptoms will be assessed from baseline (pre-intervention) to end of follow up using Acromegaly Quality of Life Questionnaire (AcroQoL).

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of acromegaly. Exclusion Criteria: Diet restrictions.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vivian Hwe

Phone

424-315-4489

Vivian.Hwe@cshs.org

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Gomez

Phone

424-315-4489

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vivian Hwe

Phone

424-315-4489

12. IPD Sharing Statement

Plan to Share IPD

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Diet in the Management of Acromegaly

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