Diabetes
Conditions
Keywords
Oral nutritional supplement, diabetes mellitus type 2, glycaemic control, Oral nutritional supplement (Food for special medical purposes)
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
Interventions
DIETARY_SUPPLEMENTOral nutritional supplement, food for special medical purposes
2 servings of 200 ml per day, treatment period: 12 weeks
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postprandial blood glucose (iAUC) (0-240 min) | day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| postprandial peak blood glucose (0-240 min) | day 1, day 42, day 84 | — |
| postprandial triglycerides (0-240 min) | day 1, day 42, day 84 | — |
| c-peptide | day 1, day 84 | — |
| total protein, albumin, prealbumin | day 1, day 42, day 84 | — |
| HbA1c, HOMA-IR index | day 1, day 42, day 84 | — |
| daily compliance | day 1-84 | in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed. |
| total cholesterol, HDL-cholesterol, LDL-cholesterol | day 1, day 42, day 84 | — |
Countries
Germany
Outcome results
None listed