Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO

Phase 1

Conditions: This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design.

Registration Number: EUCTR2004-004292-11-SE

Lead Sponsor: Endocrine Department, Sahlgrenska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Sixty patients with well defined GHD who have had GH replacement therapy for more than 3 years are eligible for participation. Patients will all be well known from our own out-patient clinic.
Inclusions criteria
•Men or women with well defined GH deficiency before commencement of GH substitution
•More than 3 years of continuous GH treatment
•Age 25-75 years
•Well-defined hypopituitary-hypothalamic disorder.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Active malignancy
•Heart failure
•Respiratory insufficiency
•Patient who may or cannot attend to the protocol according to the investigators opinion.
•Pregnancy or lactating
•Diabetes mellitus with proliferative retinopathy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim is to evaluate the short-term effects of discontinuing GH replacement therapy on quality of life and well-being in adults who have been on long-term GH replacement therapy.;Secondary Objective: Secondary aims are to study effects of discontinuing GH on:<br>•Visceral adiposity<br>•Body composition<br>•Glucose metabolism<br>•Lipid metabolism<br>•Bone metabolism<br><br>;Primary end point(s):

Secondary Outcome Measures