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

NCT01241695 | Completed

• 1 other identifier: GCOS-002-CFS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Test

EXPERIMENTAL

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

Dietary Supplement: Oral nutritional supplement, food for special medical purposes

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Oral nutritional supplement, food for special medical purposes

Interventions

Oral nutritional supplement, food for special medical purposes DIETARY_SUPPLEMENT

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

Test

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

Medical Practice

Stockach, Baden-Wurttemberg, 78333, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Dietary Supplements; Food

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Peter Mayr, Dr.

  Medical Practice, 78333 Stockach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 2, 2012

Record last verified: 2010-11

Locations

DE (1)