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

NCT ID: NCT01241695

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-12-31

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

Conditions

Diabetes

Keywords

Oral nutritional supplement, diabetes mellitus type 2, glycaemic control; Oral nutritional supplement (Food for special medical purposes)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Test

Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement

Group Type: EXPERIMENTAL

Oral nutritional supplement, food for special medical purposes

Intervention Type: DIETARY_SUPPLEMENT

2 servings of 200 ml per day, treatment period: 12 weeks

Control

Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement

Group Type: PLACEBO_COMPARATOR

Oral nutritional supplement, food for special medical purposes

Intervention Type: DIETARY_SUPPLEMENT

2 servings of 200 ml per day, treatment period: 12 weeks

Interventions

Oral nutritional supplement, food for special medical purposes

2 servings of 200 ml per day, treatment period: 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Oral nutritional supplement, food for special medical purposes

2 servings of 200 ml per day, treatment period: 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Mayr, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Practice, 78333 Stockach

Locations

Medical Practice

Stockach, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

GCOS-002-CFS

Identifier Type: -

Identifier Source: org_study_id