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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014