The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-016783-37-SE
• Date of registration: 16/10/2009
• Prospective Registration: Yes
• Primary sponsor: Sahlgrenska University Hospital
• Public title: The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH
• Scientific title: The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH
• Date of first enrolment: 07/01/2010
• Target sample size: 60
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016783-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Genotropin standard dose

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
- 30 men, age 18-70 years, with known pituitary disease and adult onset of severe isolated GHD or multiple pituitary deficiencies and waist size = 102 cm and/or BMI = 28 kg/cm2

- 30 women, age 18-70 years, with known pituitary disease and adult onset of severe isolated GHD or multiple pituitary deficiencies and osteopenia, defined as a value of bone mineral density 1.0-2.5 SD below peak bone mass or T-score within -1.5 – 2.5 SD and osteoporosis, defined as a value of bone mineral density = 2.5 SD below peak bone mass or T-score > -2.5 SD in lumbar spine, hip or total body using DEXA bone densitometry
- premenopausal women should have negative results of pregnancy test at the time of inclusion
- premenopausal women should agree to use double contraception during the study by means of p-pills and barrier anticonceptives like condoms, intrauterine spirals etc.

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:
- diabetes mellitus
- macro-albuminuria and /or serum creatinine = 150 mmol/l
- known ischemic heart disease
- Alzheimer’s disease
- Prader-Willy syndrome
- active or cured malignancy
- systemic disease
- cured Cushing disease
- cured acromegaly
- pregnancy
- lactation
- ongoing long-term (more than 5 days) treatment with glucocorticoids or known intermittent need to be treated by glucocorticoids orally or by inhalation for more than 5 days
- acute critical illness and complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions- sleep apnoea
-unidentified treatment resistent respiratory infection
-severe obesity (those patients exceeding a weight/height of 200%)
- reluctance to be randomized




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Growth hormone deficiency in adults

Intervention(s)

Product Name: Genotropin, Genotropin MiniQuick
Product Code: H01AC01
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: recombinant human growth hormone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1 mg-0.5 mg

Primary Outcome(s)

Secondary Objective: Bone mass and bone mineral mineral density in GHD adults during GH replacement therapy with very low vs. standard GH dose.

Tertiary endpoints: body composition, lipids, muscle strength and mobility, quality of life in GHD adults during GH replacement therapy with very low vs. standard GH dose.

Main Objective: Insulin sensitivity in GHD adults during GH replacement therapy with very low vs. standard GH dose. Insulin sensitivity is defined as a degree of insulin resistance- a state in which a given concentration of insulin produces a less-than-expected biological effect.

Primary end point(s): the rate of fall of blood glucose in percent per minute at iv insulin tolerance test, the measure of periferal insulin sensitivity in vivo, will be calculated using the following equation: K (glucose) = 0. 693 X 100/t1/2 (t1/2 is the time necessary for the glucose concentration to fall by one-half). Normally, the constant elimination is = 1.1%. In diabetes patients it is always <1%.

Secondary ID(s)

WS475202