Treatment of hypertension at nigth in type 1 diabetes patients with no 24 hour variation of thier bloodpressure.

Phase 1

• Conditions: Patients with type 1 diabetes with autonomic neuropathy or no 24h variation in bloodpressure.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002136-90-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-18
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Type 1 diabetes
Age 18-65 years
HbA1C < 1%
Reduced heart rate variability
Reduced 24h bloodpressure variability
Normoalbinuria and no sigs of heartdisease
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Albinuria
Se-createnine>120 mikromol/l
Sleep apnea
Workload at nigth
A history of renal arthery stenosis or renal disease/nephrectimy
Primor angiooedema or serius sideeffects during treatment with ACE-inhibitors or ANG11 - antagonist
Everyday use of NSAID up to 4 weeks before inclusion
Bad compliance
Cancer or any other significant disease that could effect the trial
Women planning a pregnancy, are pregnant or nursing
Women who do not use contraception (contraceptive pill or IUD(Intra uterine device)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Noctuenal bloodpresure reduction by antihypertensive treatment at nigth comperred with drug administration in the morning;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: Treatment of hypertension at nigth in patients with type 1 diabetes - with no 24h variation in bloodpressure implies a more suitable bloodpressure management, compared with conventional treatment (administration of drugs in the morning);Secondary Objective: Nocturnal bloodpressure treatment has a measurable effect on cardiovasculare risk factors, including left ventricular mass.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Left ventricular mass<br>Cardiac risk factors <br>Vibrationperception threshold;Timepoint(s) of evaluation of this end point: 24 weeks