Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
Not Applicable
Completed
- Conditions
- Diabetes
- Interventions
- Dietary Supplement: Oral nutritional supplement, food for special medical purposes
- Registration Number
- NCT01241695
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
- HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
- capable of using oral nutritional supplementation,
- on stable and controlled anti-diabetic regime for at least 1 months,
- use of metformin and/or sulphonylureas as oral anti-diabetic medication,
- in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition
Exclusion Criteria
- diabetes type 1,
- participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
- patients requiring a fibre free diet,
- enteral tube feed or parenteral nutrition,
- concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
- known or suspected intolerance or allergy to any component of the investigational product(s),
- any acute gastrointestinal disease within 2 weeks prior to study entry,
- gastrectomy, gastroparesis or other gastric emptying abnormalities,
- acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l) or renal failure requiring dialysis,
- cancer cachexia,
- galactosaemia, fructosaemia,
- suspicion of drug abuse, abuse of/addiction to alcohol,
- pregnant or breast feeding women, or fertile women refusing to use contraceptives,
- patients with untreated major psychiatric disorder,
- known HIV positive (safety reasons),
- patient unable to co-operate adequately
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Oral nutritional supplement, food for special medical purposes Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement Control Oral nutritional supplement, food for special medical purposes Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement
- Primary Outcome Measures
Name Time Method postprandial blood glucose (iAUC) (0-240 min) day 84
- Secondary Outcome Measures
Name Time Method postprandial peak blood glucose (0-240 min) day 1, day 42, day 84 postprandial triglycerides (0-240 min) day 1, day 42, day 84 total cholesterol, HDL-cholesterol, LDL-cholesterol day 1, day 42, day 84 total protein, albumin, prealbumin day 1, day 42, day 84 HbA1c, HOMA-IR index day 1, day 42, day 84 c-peptide day 1, day 84 gastrointestinal tolerance week 1, week 6, week 12 palatability / taste test week 1, week 6, week 12 by means of a sensorial questionnaire the patients will evaluate the overall liking, appearance, smell, taste, mouth feel et cetera of the study nutrition.
daily compliance day 1-84 in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed.
Trial Locations
- Locations (1)
Medical Practice
🇩🇪Stockach, Baden-Württemberg, Germany