Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients

Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients : What About Their Consequences ?

The diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.

Study Overview

• Status: Recruiting
• Conditions: Acromegaly

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Lucile MARTY, intern; Phone Number: 33 06.71.31.76.37; Email: lucile-marty@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Lucile MARTY, intern; Phone Number: 33 06.71.31.76.37; Email: lucile-marty@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult acromegalic patient followed up in the Occitanie region (independent endocrinologist ou working in hospital of Montpellier, Nimes or Béziers)

Description

Inclusion criteria:

• Acromegaly followed up in one of the center (Montpellier, Nimes or Béziers hospital, independent endocrinologist) between 2010 and 2021
• Age over 18 years old
• Measurement of GH and IGF1 rates at the last visit control available

Exclusion criteria:

• Lost to follow-up
• Status about complications related to acromegaly unknown

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of complications and/or recidivism related to acromegaly	The investigators check in the patient file if there is complications or pathology recidivism detected at the last full check-up of the disease, assessed by blood-control and complementary exams	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease's specificity	The investigators collected datas about disease's diagnosis (IRM characteristic, GH/IGF1 rates, clinical presentation) to evaluate if there is a different initial presentation between groups.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Isabelle RAINGEARD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Acromegaly; Endocrinology; Complications; Discrepancy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: RECHMPL21_0229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No