Diabetic Nephropathy
Conditions
Interventions
Product Name: SUPERGUM
Product Code: 060363
Pharmaceutical Form: Powder for oral suspension
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Individuals with poorly controlled blood pressure systolic >160mmHg and/or diastolic>100mmHg. 2. Individuals with overt proteinuria. 3. individuals intolerant of gum arabic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed