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 Overview
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Brief Summary
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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

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplement, food for special medical purposes
* Dietary Supplement: Oral nutritional supplement, food for special medical purposes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement | Dietary Supplement: Oral nutritional supplement, food for special medical purposes<br>* 2 servings of 200 ml per day, treatment period: 12 weeks<br>|
| Placebo Comparator: Control<br>Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement | Dietary Supplement: Oral nutritional supplement, food for special medical purposes<br>* 2 servings of 200 ml per day, treatment period: 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial blood glucose (iAUC) (0-240 min) |  | day 1 | 
| postprandial blood glucose (iAUC) (0-240 min) |  | day 42 | 
| postprandial blood glucose (iAUC) (0-240 min) |  | day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial peak blood glucose (0-240 min) |  | day 1, day 42, day 84 | 
| postprandial triglycerides (0-240 min) |  | day 1, day 42, day 84 | 
| total cholesterol, HDL-cholesterol, LDL-cholesterol |  | day 1, day 42, day 84 | 
| total protein, albumin, prealbumin |  | day 1, day 42, day 84 | 
| HbA1c, HOMA-IR index |  | day 1, day 42, day 84 | 
| c-peptide |  | day 1, day 84 | 
| gastrointestinal tolerance |  | week 1, week 6, week 12 | 
| palatability / taste test | by means of a sensorial questionnaire the patients will evaluate the overall liking, appearance, smell, taste, mouth feel et cetera of the study nutrition. | week 1, week 6, week 12 | 
| daily compliance | in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed. | day 1-84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplement, diabetes mellitus type 2, glycaemic control, Oral nutritional supplement (Food for special medical purposes)