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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: Oral nutritional supplement, food for special medical purposes

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stockach, Baden-Württemberg, Germany, 78333
      • Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Peter Mayr, Dr., Medical Practice, 78333 Stockach

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 10, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 29, 2012
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Oral nutritional supplement, diabetes mellitus type 2, glycaemic control; Oral nutritional supplement (Food for special medical purposes)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: GCOS-002-CFS