Diet in the Management of Acromegaly
Primary Purpose
Acromegaly
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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
No
Learn more about this trial
Diet in the Management of Acromegaly
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