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 Kabi

Status

Completed

Conditions

Diabetes

Treatments

Dietary Supplement: Oral nutritional supplement, food for special medical purposes

Study type

Interventional

Funder types

Industry

Identifiers

NCT01241695

GCOS-002-CFS

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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