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

Fresenius Kabi1 site in 1 country40 target enrollmentNovember 2010

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Fresenius Kabi
Enrollment: 40
Locations: 1
Primary Endpoint: postprandial blood glucose (iAUC) (0-240 min)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

December 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fresenius Kabi

Responsible Party

Sponsor

Eligibility Criteria

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,