Reproducibility and Utility of OGTT in Acromegaly (NCT04066569) | Clinical Trial Compass
CompletedNot Applicable
Reproducibility and Utility of OGTT in Acromegaly
France109 participantsStarted 2020-08-24
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* 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.
Non-acromegalic subjects:
* Men or women, adults ≤ 85 years
* Subjects defined by a concentrat…
What they're measuring
1
Compare Nadir GH concentration in μg/L obtained in two OGTT in the same subject with acromegaly
Timeframe: The two test will be separated by the preiod of 24h - 30 days