Diurnal variation of exogenous peptides - Gh Puls/Jurgita I

Phase 1

• Conditions: Adults with growth hormone disease (AGHD).

• Registration Number: EUCTR2010-018586-39-DK
• Lead Sponsor: Medical Department M (Endocrinology & Diabetes)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Informed consent
2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
3. Stable GH replacement therapy for at least 3 months
4. Body Mass Index (BMI, kg/m2) from 18,5 to 35.0 kg/m2, both inclusive
5. Achieved final height
6. Age = 18 years

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

1. AGHD subjects with active malignancy
2. Severe cardiac insufficiency classified according to NYHA III-IV
3. Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
4. Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
5. HbA1C > 7,5 %
6. Impaired kidney function: serum creatinine = 150 umol/l according to the hospital lab.
7. Patients on insulin treatment
8. Stable pituitary replacement therapy for less than 3 months
9. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
10. Any diseases judged by the investigator that could affect the trial
11. Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, intrauterine device (IUD), hysterectomy or sterilization
12. Known or suspected allergy to the trial product or ingredients of the trial product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified