NCT05401084

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

May 23, 2022

Last Update Submit

April 17, 2024

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • Change in growth hormone level (GH).

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

    8 weeks

  • 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).

    8 weeks

Study Arms (3)

Carbohydrate

ACTIVE COMPARATOR

Counseling, education, and implementation of low carbohydrate diet.

Other: Diet

Low gluten

ACTIVE COMPARATOR

Counseling, education, and implementation of low gluten diet.

Other: Diet

Standard

NO INTERVENTION

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

Interventions

DietOTHER

Macronutrient diet changes.

CarbohydrateLow gluten

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acromegaly.

You may not qualify if:

  • Diet restrictions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Acromegaly

Interventions

Diet

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Vivian Hwe

CONTACT

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

Daniel Gomez

CONTACT

424-315-4489

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

September 20, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)