AcromegalyACROTESTNCT04066569
Reproducibility and Utility of OGTT in Acromegaly
A study testing Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose) in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Prospective study of reproducibility and utility of growth hormone inhibition by oral glucose tolerance test for the diagnosis of acromegaly, in acromegalic and non-acromegalic subjects, with a randomized double-blind crossover over placebo arm in the group of acromegalic patients Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 24 Aug 2020to 5 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acromegalic subjects
- Men or women, adults ≤ 85 years, with hypersecretion of GH proven by the following criteria:
- High IGF-I compared to age and sex standards (Variety study, Chanson et al., 2016)
- and basal GH concentrations > 0.4 μg / L (Katznelson, et al., 2014) and somatotropic pituitary adenoma operated on or planned to be operated on. It may be patients whose acromegaly has just been discovered and not yet treated (de novo patients) for whom a surgical treatment is envisaged within 6 months after inclusion or acromegalic patients already operated on a pituitary adenoma whose acromegaly is not controlled by surgery. A histological confirmation of a somatotropic pituitary adenoma will be obtained either before inclusion in the study (subjects already operated) or after inclusion ("de novo" subjects) in order to have a sufficient level of proof of the diagnosis of acromegaly, especially in the "intermediate" forms.
- Medically treated patients who decide to discontinue treatment (in order to reassess the progression of the disease, or at the time of a change), will be eligible after more than 3 months of discontinuation of the drug treatment.
- In women on estrogen / progestin contraception, this should be kept unchanged throughout the study. In the absence of estrogen / progestin contraception, exploration will be done in the follicular phase.
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- Non-acromegalic subjects:
- Men or women, adults ≤ 85 years
- Subjects defined by a concentration of IGF-I below 100% of the upper limit of normal, matched for sex and age (± 5 years) to acromegalic patients.
- Normal blood pressure measured by an electronic tensiometer validated after 5 min resting in supine position <140/90 mmHg on 3 consecutive measurements
- Biological assessment (hematological and biochemical blood tests, urine analysis) within the limits of normal or clinically acceptable. Normal EKG.
- ECG 12 leads without particularity.
- Affiliation to a social security scheme
- At the women on estrogen-progestative contraception, this one should be kept unchanged throughout the study. In the absence of estrogen-progestative contraception,the exploration will be done in the follicular phase.
- Signed informed consent.
Who cannot join
- For both groups:
- Pregnant or breastfeeding women
- Acute systemic diseases
- Pathologies likely to affect digestive absorption
- Taking prohibited treatments (see section 7.3)
- History of hypersensitivity to aspartame (edema of Quincke, Urticaria ..)
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- Donation of blood in the 3 months preceding the study
- People in the exclusion period on the national file people suitable for research involving the human person
- Refusal or linguistic or psychic incapacity to sign informed consent
- Subject unable to submit to the constraints of the protocol (for example, non-cooperating, unable to return to follow-up visits and probably unable to finish the study)
- Major under guardianship
- Major under curatorship
- People with phenylketonuria
- Person with digestive intolerance to glucose /galactose, digestive labsorption syndrome of glucose / galactose.
- For the group of acromegalic patients:
- acromegalic patients with diabetes mellitus treated with insulin
- Acromegalic patients under medical treatment of their acromegaly somatostatin analogues, pegvisomant), or patients in whom this treatment has been suspended for less than 3 months at the time of the selection.
- Acromegalic patients who have been treated with radiotherapy.
- For the group of non-acromegalic subjects:
- Chronic systemic diseases likely to influence the secretion of GH like diabetes sweetness, severe obesity (BMI> 35 kg / m2), inadequate renal (creatinine clearance <60 mL / min), disease hypothalamic-pituitary, epilepsy, antecedents Hepatocellular insufficiency and insufficiency cardiac, progressive cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility and Utility of Growth Hormone Inhibition by Oral Glucose Tolerance Test for the Diagnosis of Acromegaly
Prospective study of reproducibility and utility of growth hormone inhibition by oral glucose tolerance test for the diagnosis of acromegaly, in acromegalic and non-acromegalic subjects, with a randomized double-blind crossover over placebo arm in the group of acromegalic patients
Read the detailed description
Rational: The initial step of biological diagnosis of acromegaly is based on assessment of IGF-I. According to current recommendations, the diagnosis must be confirmed by an oral glucose tolerance test (OGTT) to show that there is no growth hormone (GH) decrease lower than 1 μg/L (Katznelson , et al., 2014).
Reproducibility of GH suppression by the OGTT has never been evaluated in either acromegalic or healthy subjects, although it is essential to determine the reliability of this test. Spontaneous fluctuations in GH in acromegaly could significantly influence the response of GH to the OGTT and cause low reproducibility of the test in this population. In particular, this reliability could be different according to the typical or moderate clinical presentation because of the persistence of a residual ultradian rhythm of GH secretion.
The usefulness of oral glucose loading and the resulting hyperglycemia (which may limit GH secretion) has never been compared to an appropriate placebo (aspartame, at a dose equivalent to 75 g glucose), which does not cause hyperglycemia. Ingestion of 75 g of glucose is often responsible for nausea and vomiting. More rarely, the drop in blood glucose reactive to hyper insulinemia at the end of the test, can be the cause of discomfort.
Primary objective: To determine the reproducibility of the GH response to OGTT in acromegaly by studying, in subjects with acromegaly, changes in GH concentration within 2 hours after oral administration of 75 g of glucose at 2 repeated tests in the same subject.
Secondary objectives:
- To analyze the reproducibility of the GH response to the OGTT as a function of the severity of acromegaly ("typical" form, "intermediate" form of acromegaly) and in a group of non-acromegalic subjects.
- To evaluate the diagnostic value (utility) of OGTT in acromegaly by comparing, in subjects with acromegaly, the response of GH to oral administration of 75 g of glucose (OGTT) and 375 mg of aspartame (placebo).
- Evaluate OGTT-stimulated insulin secretion in acromegalic and non-acromegalic subjects.
- Conditions
- Acromegaly
- Being tested
- Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of Aspartam, Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)
- Keywords
- Diagnostic test, Growth hormone, oral glucose tolerance test
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of AspartamOther
After inclusion, the study will include the sequential realization of 3 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 200 mL of water) and a placebo test (oral administration of 375 mg of aspartame in 200 mL of water). The order of the three tests (2 OGTT and 1 placebo) in acromegalic patients will be randomized.
The tests will be performed under the same conditions
Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)Other
After inclusion, the study will include the sequential realization of 2 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 200 mL of water).
The tests will be performed under the same conditions (fasting, semi-recumbent position, start of the test at 9 am) and will include a measurement of blood glucose, GH, insulinemia at -15, 0, 30, 60, 90, 120 min after ingestion of glucose or placebo.
| Study group | Role | What they receive |
|---|---|---|
| OGTT Tests and Placebo Test | Active comparator | Patients with acromegaly Receives: Other: Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of Aspartam |
| OGTT Tests | Active comparator | age and sex matched healthy volunteers Receives: Other: Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Nadir GH concentration in μg/L obtained in two OGTT in the same subject with acromegaly
GH will be measured by an immunometric chemiluminescent assay on an Immulite 2000XPi (Siemens Healthcare Diagnostics, Erlangen, Germany) on venous blood samples at -15 min, 0 min, 30 min, 60 min, 90 min, 120 min after ingestion of 75g of glucose
Measured: The two test will be separated by the preiod of 24h - 30 days
Secondary outcomes (3)
Severity of acromegaly ("typical" form, "intermediate" form of acromegaly)
"Typical" form of acromegaly defined by an IGF-I concentration> 200% of the upper limit of normal, in the presence of a somatotropic pituitary adenoma
- moderate or "intermediate" form of acromegaly defined by an IGF-I concentration value between 100% and 200% of the upper limit of normal, in the presence of a somatotropic pituitary adenoma. The IGF-I reference values determined by sex and age in the "Variety" study will be used for this classification
Measured: The two test will be separated by the preiod of 24h - 30 days
Nadir GH in mIU / L (conversion 1 μg / L = 3 mIU / L) obtained in the two OGTT tests and the placebo (aspartame) test repeated in the same subject (acromegalic and non acromegalic)
Nadir GH in ug/L obtained in the two OGTT tests and the placebo (aspartame) test repeated in the same subject. GH will be measured by an immunometric chemiluminescent assay on an Immulite 2000XPi (Siemens Healthcare Diagnostics, Erlangen, Germany) on venous blood samples at -15 min, 0 min , 30 min , 60 min , 90 min , 120 min after ingestion of 75g of glucose / 375g of aspartame
Measured: Each test will be separated by the preiod of 24h - 30 days
Peak glucose level in both OGTT and placebo tests
Verification of hyperglycemia induced or not depending on the product administered
Measured: Each test will be separated by the preiod of 24h - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start24 Aug 2020
- Primary completion30 Oct 2024
- Study completion5 Mar 2025
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 Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066569
- Sponsor's protocol ID
- P170917J
- Acronym
- ACROTEST
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2019
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility and Utility of Growth Hormone Inhibition by Oral Glucose Tolerance Test for the Diagnosis of Acromegaly
- ClinicalTrials.gov ID
- NCT04066569
- Acronym / sponsor ID
- ACROTEST / P170917J
- Conditions
- Acromegaly
- Keywords
- Diagnostic test, Growth hormone, oral glucose tolerance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 26 Aug 2019 (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.
Prospective study of reproducibility and utility of growth hormone inhibition by oral glucose tolerance test for the diagnosis of acromegaly, in acromegalic and non-acromegalic subjects, with a randomized double-blind crossover over placebo arm in the group of acromegalic patients
Detailed description
Rational: The initial step of biological diagnosis of acromegaly is based on assessment of IGF-I. According to current recommendations, the diagnosis must be confirmed by an oral glucose tolerance test (OGTT) to show that there is no growth hormone (GH) decrease lower than 1 μg/L (Katznelson , et al., 2014).
Reproducibility of GH suppression by the OGTT has never been evaluated in either acromegalic or healthy subjects, although it is essential to determine the reliability of this test. Spontaneous fluctuations in GH in acromegaly could significantly influence the response of GH to the OGTT and cause low reproducibility of the test in this population. In particular, this reliability could be different according to the typical or moderate clinical presentation because of the persistence of a residual ultradian rhythm of GH secretion.
The usefulness of oral glucose loading and the resulting hyperglycemia (which may limit GH secretion) has never been compared to an appropriate placebo (aspartame, at a dose equivalent to 75 g glucose), which does not cause hyperglycemia. Ingestion of 75 g of glucose is often responsible for nausea and vomiting. More rarely, the drop in blood glucose reactive to hyper insulinemia at the end of the test, can be the cause of discomfort.
Primary objective: To determine the reproducibility of the GH response to OGTT in acromegaly by studying, in subjects with acromegaly, changes in GH concentration within 2 hours after oral administration of 75 g of glucose at 2 repeated tests in the same subject.
Secondary objectives:
- To analyze the reproducibility of the GH response to the OGTT as a function of the severity of acromegaly ("typical" form, "intermediate" form of acromegaly) and in a group of non-acromegalic subjects.
- To evaluate the diagnostic value (utility) of OGTT in acromegaly by comparing, in subjects with acromegaly, the response of GH to oral administration of 75 g of glucose (OGTT) and 375 mg of aspartame (placebo).
- Evaluate OGTT-stimulated insulin secretion in acromegalic and non-acromegalic subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGTT Tests and Placebo Test | Active comparator | Other: Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of AspartamPatients with acromegaly |
| OGTT Tests | Active comparator | Other: Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)age and sex matched healthy volunteers |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Acromegalic subjects
- Men or women, adults ≤ 85 years, with hypersecretion of GH proven by the following criteria:
- Medically treated patients who decide to discontinue treatment (in order to reassess the progression of the disease, or at the time of a change), will be eligible after more than 3 months of discontinuation of the drug treatment.
- In women on estrogen / progestin contraception, this should be kept unchanged throughout the study. In the absence of estrogen / progestin contraception, exploration will be done in the follicular phase.
- Men or women, adults ≤ 85 years
Key exclusion criteria (20 listed)
- Pregnant or breastfeeding women
- Acute systemic diseases
- Pathologies likely to affect digestive absorption
- Taking prohibited treatments (see section 7.3)
- History of hypersensitivity to aspartame (edema of Quincke, Urticaria ..)
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 |
|---|---|---|
| Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of AspartamAfter inclusion, the study will include the sequential realization of 3 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 200 mL of water) and a placebo test (oral administration of 375 mg of aspartame in 200 mL of water). The order of the three tests (2 OGTT and 1 placebo) in acromegalic patients will be randomized. The tests will be performed under the same conditions | Other | OGTT Tests and Placebo Test |
| Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)After inclusion, the study will include the sequential realization of 2 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 200 mL of water). The tests will be performed under the same conditions (fasting, semi-recumbent position, start of the test at 9 am) and will include a measurement of blood glucose, GH, insulinemia at -15, 0, 30, 60, 90, 120 min after ingestion of glucose or placebo. | Other | OGTT Tests |
Primary outcome
Compare Nadir GH concentration in μg/L obtained in two OGTT in the same subject with acromegaly
Time frame: The two test will be separated by the preiod of 24h - 30 days
GH will be measured by an immunometric chemiluminescent assay on an Immulite 2000XPi (Siemens Healthcare Diagnostics, Erlangen, Germany) on venous blood samples at -15 min, 0 min, 30 min, 60 min, 90 min, 120 min after ingestion of 75g of glucose
3 secondary outcomes
Severity of acromegaly ("typical" form, "intermediate" form of acromegaly)
Time frame: The two test will be separated by the preiod of 24h - 30 days
Nadir GH in mIU / L (conversion 1 μg / L = 3 mIU / L) obtained in the two OGTT tests and the placebo (aspartame) test repeated in the same subject (acromegalic and non acromegalic)
Time frame: Each test will be separated by the preiod of 24h - 30 days
Peak glucose level in both OGTT and placebo tests
Time frame: Each test will be separated by the preiod of 24h - 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose) in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 15 inclusion and 20 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: finished, as of the sponsor's last update on 24 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Nadir GH concentration in μg/L obtained in two OGTT in the same subject with acromegaly (time frame: The two test will be separated by the preiod of 24h - 30 days). 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 24 Nov 2025.