The effects of Acacia (sen) SUPERGUM (Gum Arabic) on renal physiology and arterial function in type II diabetic patients
- Conditions
- Diabetic Nephropathy
- Registration Number
- EUCTR2005-003681-42-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1. Individuals with diabetes should have stable renal function in the 6 months prior to commencing study based on calculated creatinine clearance (>100ml/min) by the cockcroft gault formula.
2 Females of childbearing age must have a negative pregnancy test prior to the inclusion period. Effective contraception must be used.
3. Patients willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
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
1. Individuals with poorly controlled blood pressure systolic >160mmHg and/or diastolic>100mmHg.
2. Individuals with overt proteinuria.
3. individuals intolerant of gum arabic.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To examine the effects on renal haemodynamics of a high fibre dietary supplementation in patients with diabetic nephropathy.;Secondary Objective: To examine the effects on cardiovascular function of a high fibre dietary supplementation in patients with diabetic nephropathy.;Primary end point(s): End point is completion of 12 week course of gum arabic dietary supplement plus a washout period of a further 8 weeks.
- Secondary Outcome Measures
Name Time Method