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Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients


Phase 4
18 Years
50 Years
Not Enrolling
Male
Hypopituitarism, Pituitary Tumors, Growth Hormone Deficiency

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Trial Information

Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients


This is an observational,5-yr prospective, controlled study. At study entry, all subjects
underwent serum assay of IGF-I, systolic and diastolic blood pressure (SBP, DBP)
measurement, total-, and HDL-cholesterol, triglycerides, glucose, and insulin level after an
overnight fasting, and common carotid arteries ultrasonography. The oral glucose load (oGTT)
was performed by measuring blood glucose every 30 minutes for 2 hours after the oral
administration of 75 g of glucose diluted in 250 ml of saline solution. The conversion
factors (mg/dl to mmol/l) for lipids and glucose were as follows: cholesterol 0.02586,
triglycerides 0.01129, and glucose 0.05551. According with previous studies (13,19-21) blood
pressure was measured at the right arm, with the subjects in relaxed sitting position. The
average of six measurements (three taken by each of two examiners, in the same day, between
8.00-9.00 in the morning) with a mercury sphygmomanometer was used in all analysis.

In the patients, all parameters and carotid ultrasonography were re-evaluated after 12, 24,
36, 48 and 60 months while in controls they were re-evaluated after 60 months.

At study entry and at study end, in all of the patients and controls the prevalence of
insulin-resistance syndrome (IRS) was evaluated according with the American College of
Endocrinology (14) based on the presence of at least two criteria of the following:
triglycerides levels ≥1.7 mmol/liter, HDL-cholesterol levels ≤1.0 mmol/liter, blood pressure
above 130/85 mmHg, fasting glucose between 6.1 and 7 mmol/liter or 2 hr after oGTT between
7.7 and 11.1 mmol/liter.


Inclusion Criteria:



- male gender

- age <50 yrs to limit the effect of aging;

- body mass index <30 Kg/m2;

- no familial or personal history of cardiovascular diseases;

- no concomitant treatment with drugs known to interfere with glucose or lipid
metabolism or to influence blood pressure at the time of study entry;

- no previous GH treatment

Exclusion Criteria:

- female gender

- age >50 yrs;

- body mass index ≥30;

- familial or personal history of cardiovascular diseases;

- previous and present treatments with drugs known to interfere with glucose or lipid
metabolism or to influence blood pressure;

- previous GH treatment in adult age

- GHD of childhood onset

- GHD due to previous Cushing's disease

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Intima-media thickness at common carotid arteries at baseline and after 5 years

Outcome Time Frame:

5 yrs

Principal Investigator

Annamaria AL Colao, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University "Federico II"

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

NeuroendoUnit-3

NCT ID:

NCT00462475

Start Date:

January 1996

Completion Date:

December 2006

Related Keywords:

  • Hypopituitarism
  • Pituitary Tumors
  • Growth Hormone Deficiency
  • GH
  • IGF-I
  • GH deficiency
  • Atherosclerosis
  • Insulin resistance syndrome
  • Atherosclerosis
  • Dwarfism, Pituitary
  • Hypopituitarism
  • Pituitary Neoplasms
  • Endocrine System Diseases

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