Growth hormone deficiency and clotting

Elucidation of the effects of growth hormone (GH) deficiency and GH replacement on vascular risk and clot dynamics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN59234325

Enrollment

140

Registered

2013-01-29

Start date

2013-04-01

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hypothalamo-pituitary pathology, proven to be severely growth hormone deficient Nutritional, Metabolic, Endocrine Idiopathic growth hormone deficiency

Interventions

For patients and controls measures will be performed at baseline and repeated in the patients alone after growth hormone dose optimisation and three months on the ideal dose. Measurements include: 1.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to give written consent 2. Adults over age 18 years, and of either gender with confirmed GHD (insulin stimulation test <3 ug/L) 3. Other hormone replacement therapy stable for at least three months

Exclusion criteria

Exclusion criteria: 1. Active malignancy 2. An acute vascular event within three months of the study 3. Any therapy other than hormone replacement 4. Serum creatinine >120 mol/l 5. Abnormal liver function tests (LFTs) [alanine transaminase (ALT) >3 fold upper limit of normal]

Design outcomes

Primary

Measure	Time frame
Turbidity analysis	—

Secondary

Measure	Time frame
1. Inflammatory, fibrinolytic, procoagulant markers 2. Lipids 3. 24-hour blood pressure 4. Body composition Measurements will occur prior to commencing growth hormone replacement, and having been on a stable dose of growth hormone for three months. Measurement of body fat and muscle will be performed using an electrical scale (bioimpedence analysis) and X-ray absorptiometry. The latter uses low dose X-rays to differentiate between fat, muscle and bone. Levels of blood fats, sugar, clotting factors etc will be measured using standard laboratory assays. Rates of clot formation and breakdown will be assessed in the laboratory by measurements of changes in optical density using a spectrophotometer (measures changes in light) both at the beginning of the clotting reaction and after formation of the mature clot.	—

Measure

Time frame

1. Inflammatory, fibrinolytic, procoagulant markers 2. Lipids 3. 24-hour blood pressure 4. Body composition Measurements will occur prior to commencing growth hormone replacement, and having been on a stable dose of growth hormone for three months. Measurement of body fat and muscle will be performed using an electrical scale (bioimpedence analysis) and X-ray absorptiometry. The latter uses low dose X-rays to differentiate between fat, muscle and bone. Levels of blood fats, sugar, clotting factors etc will be measured using standard laboratory assays. Rates of clot formation and breakdown will be assessed in the laboratory by measurements of changes in optical density using a spectrophotometer (measures changes in light) both at the beginning of the clotting reaction and after formation of the mature clot.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026