Effects of Hintonia latiflora in type 2 diabetics
- Conditions
- Mild and moderate diabetes mellitus of type II (age-related)Nutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN83308122
- Lead Sponsor
- Gehrlicher Pharmazeutische Extrakte GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Type 2 diabetics
2. Between the ages of 45 and 80
3. Neither oral antidiabetic agents nor insulin were used
4. Prescribed diet had led to stable but not nearly normoglycaemic values
As a condition for inclusion in the study, diabetic symptoms must have existed for a period of at least 12 months. The values for fasting blood sugar had to be in the range from 7-14 mmol/l (normal value: 3.9-5.4 mmol/l).
To be excluded were patients for whom there was a doubt about the reliability with respect to the adherence to the dietetic guidelines (e.g., with regard to alcohol consumption). Other exclusion reasons were severe diabetic symptoms, progressive life-threatening diseases, hepatic dysfunction or renal insufficiency (deviations of GOT, ?GT and AP of more than twice the normal value, serum creatinine > 130 µmol/l), hypoglycaemic crises not noticed in time, retinopathy, pregnancy, malignant tumours and/or drug or alcohol dependence in the medical history.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting blood sugar and postprandial blood sugar (two hours after food intake) as well as blood pressure and body weight were recorded at monthly intervals. The HbA1c value was recorded after three and six months as were the liver values and blood lipids.
- Secondary Outcome Measures
Name Time Method 1. Safety laboratory including liver function tests<br>2. Physical symptoms<br>3. Adverse events