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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT01241695
First received: November 10, 2010
Last updated: June 29, 2012
Last verified: November 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • postprandial blood glucose (iAUC) (0-240 min) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • postprandial blood glucose (iAUC) (0-240 min) [ Time Frame: day 42 ] [ Designated as safety issue: No ]
  • postprandial blood glucose (iAUC) (0-240 min) [ Time Frame: day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postprandial peak blood glucose (0-240 min) [ Time Frame: day 1, day 42, day 84 ] [ Designated as safety issue: No ]
  • postprandial triglycerides (0-240 min) [ Time Frame: day 1, day 42, day 84 ] [ Designated as safety issue: Yes ]
  • total cholesterol, HDL-cholesterol, LDL-cholesterol [ Time Frame: day 1, day 42, day 84 ] [ Designated as safety issue: No ]
  • total protein, albumin, prealbumin [ Time Frame: day 1, day 42, day 84 ] [ Designated as safety issue: No ]
  • HbA1c, HOMA-IR index [ Time Frame: day 1, day 42, day 84 ] [ Designated as safety issue: No ]
  • c-peptide [ Time Frame: day 1, day 84 ] [ Designated as safety issue: No ]
  • gastrointestinal tolerance [ Time Frame: week 1, week 6, week 12 ] [ Designated as safety issue: Yes ]
  • palatability / taste test [ Time Frame: week 1, week 6, week 12 ] [ Designated as safety issue: No ]
    by means of a sensorial questionnaire the patients will evaluate the overall liking, appearance, smell, taste, mouth feel et cetera of the study nutrition.

  • daily compliance [ Time Frame: day 1-84 ] [ Designated as safety issue: No ]
    in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed.


Enrollment: 40
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241695

Locations
Germany
Medical Practice
Stockach, Baden-Württemberg, Germany, 78333
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Peter Mayr, Dr. Medical Practice, 78333 Stockach
  More Information

No publications provided

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT01241695     History of Changes
Other Study ID Numbers: GCOS-002-CFS
Study First Received: November 10, 2010
Last Updated: June 29, 2012
Health Authority: Germany: Ethics committee

Keywords provided by Fresenius Kabi:
Oral nutritional supplement, diabetes mellitus type 2, glycaemic control
Oral nutritional supplement (Food for special medical purposes)

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014