ClinicalTrials.gg
RecruitingNCT05401084Updated Apr 19, 2024

Diet in the Management of Acromegaly

An interventional study of Diet in Acromegaly, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Acromegaly

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03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's planned enrollment of 9 is below the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of acromegaly.

Exclusion criteria

Exclusion Criteria:

  • Diet restrictions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Active comparator
    Carbohydrate

    Counseling, education, and implementation of low carbohydrate diet.

    Other: Diet

  • Active comparator
    Low gluten

    Counseling, education, and implementation of low gluten diet.

    Other: Diet

  • No intervention
    Standard

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

Interventions

  • OtherDiet

    Macronutrient diet changes.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. Change in growth hormone level (GH).

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

    Time frame: 8 weeks

  3. 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).

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2024; primary completion for Mar 2025, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2022
First posted
Jun 2, 2022
StartEst.
Sep 20, 2024
Primary completionEst.
Mar 1, 2025
CompletionEst.
Mar 1, 2025
Last update
Apr 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05401084
Responsible party
Artak Labadzhyan (Assistant professor, Cedars-Sinai Medical Center) — Principal investigator
First posted
Jun 2, 2022
Start date
Sep 20, 2024 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Apr 19, 2024

Study contacts

Vivian Hwe
Contact
Vivian.Hwe@cshs.org
424-315-4489
Daniel Gomez
Contact
424-315-4489

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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