Reproducibility and Utility of OGTT in Acromegaly

NCT04066569 | Completed

• 1 other identifier: P170917J
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acromegaly

Keywords

Diagnostic test; Growth hormone; oral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  Each test will be separated by the preiod of 24h - 30 days

• Peak glucose level in both OGTT and placebo tests

  Each test will be separated by the preiod of 24h - 30 days

Study Arms (2)

OGTT Tests and Placebo Test

ACTIVE COMPARATOR

Patients with acromegaly

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

Other: Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)

Interventions

Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of Aspartam OTHER

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

OGTT Tests and Placebo Test

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.

OGTT Tests

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.
• 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.

You may not qualify if:

• 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 ..)
• Donation of blood in the 3 months preceding the study
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Glucose; Aspartame

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: August 24, 2020
• Primary Completion: October 30, 2024
• Study Completion: March 5, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)