AcromegalyNCT05401084
Diet in the Management of Acromegaly
A study testing Diet in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acromegaly.
Who cannot join
- Diet restrictions.
Trial locations and contacts
1 site in 1 country.
Daniel Gomez contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vivian Hwe, 424-315-4489
About this study
Official title: Impact of Low Carbohydrate and Low Gluten Diet on Acromegaly Progression, Symptoms, Complications, and Treatment Outcomes
Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.
- Conditions
- Acromegaly
- Being tested
- Diet
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Macronutrient diet changes.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate | Active comparator | Counseling, education, and implementation of low carbohydrate diet. Receives: Other: Diet |
| Low gluten | Active comparator | Counseling, education, and implementation of low gluten diet. Receives: Other: Diet |
| Standard | No intervention | No change/intervention in diet. Continuation of standard diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Change in growth hormone level (GH).
Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start20 Sep 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artak Labadzhyan, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401084
- Sponsor's protocol ID
- STUDY00001851
- Status last verified
- Apr 2024
- First submitted
- 23 May 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Carbohydrate and Low Gluten Diet on Acromegaly Progression, Symptoms, Complications, and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT05401084
- Acronym / sponsor ID
- STUDY00001851
- Conditions
- Acromegaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Active comparator | Other: DietCounseling, education, and implementation of low carbohydrate diet. |
| Low gluten | Active comparator | Other: DietCounseling, education, and implementation of low gluten diet. |
| Standard | No intervention | –No change/intervention in diet. Continuation of standard diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of acromegaly.
Key exclusion criteria (1 listed)
- Diet restrictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietMacronutrient diet changes. | Other | Carbohydrate, Low gluten |
Primary outcome
Change in insulin-like growth factor 1 (IGF-1).
Time frame: 8 weeks
Change in IGF-1 will be assessed from baseline (pre-intervention) to end of follow up.
Change in growth hormone level (GH).
Time frame: 8 weeks
Change in GH level will be assessed from baseline (pre-intervention) to end of follow up.
Change in acromegaly related symptoms.
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Gomez contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivian Hwe (424-315-4489, Vivian.Hwe@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin-like growth factor 1 (IGF-1). (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.