Status:
COMPLETED
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
Lead Sponsor:
Fresenius Kabi
Conditions:
Diabetes
Eligibility:
All Genders
40+ years
Phase:
NA
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 diabet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01241695
Start Date
November 1 2010
End Date
December 1 2011
Last Update
July 2 2012
Active Locations (1)
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1
Medical Practice
Stockach, Baden-Wurttemberg, Germany, 78333