Clinical trial NCT01241695: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Oral nutritional supplement, diabetes mellitus type 2, glycaemic control
Oral nutritional supplement (Food for special medical purposes)
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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,
* 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

Primary outcomes:
measure: postprandial blood glucose (iAUC) (0-240 min)
timeFrame: day 1
measure: postprandial blood glucose (iAUC) (0-240 min)
timeFrame: day 42
measure: postprandial blood glucose (iAUC) (0-240 min)
timeFrame: day 84
Secondary outcomes:
measure: postprandial peak blood glucose (0-240 min)
timeFrame: day 1, day 42, day 84
measure: postprandial triglycerides (0-240 min)
timeFrame: day 1, day 42, day 84
measure: total cholesterol, HDL-cholesterol, LDL-cholesterol
timeFrame: day 1, day 42, day 84
measure: total protein, albumin, prealbumin
timeFrame: day 1, day 42, day 84
measure: HbA1c, HOMA-IR index
timeFrame: day 1, day 42, day 84
measure: c-peptide
timeFrame: day 1, day 84
measure: gastrointestinal tolerance
timeFrame: week 1, week 6, week 12
measure: palatability / taste test
timeFrame: week 1, week 6, week 12
measure: daily compliance
timeFrame: day 1-84
Other outcomes:
Locations:
city: Stockach
country: Germany
facility: Medical Practice
state: Baden-Württemberg
Study officials:
affiliation: Medical Practice, 78333 Stockach
name: Peter Mayr, Dr.
role: PRINCIPAL_INVESTIGATOR
References: