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

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241695
• Other study ID #: GCOS-002-CFS
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: June 29, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2010
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Oral nutritional supplement, food for special medical purposes
2 servings of 200 ml per day, treatment period: 12 weeks
• Oral nutritional supplement, food for special medical purposes
2 servings of 200 ml per day, treatment period: 12 weeks

Locations

Country	Name	City	State
Germany	Medical Practice	Stockach	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial blood glucose (iAUC) (0-240 min)		day 1	No
Primary	postprandial blood glucose (iAUC) (0-240 min)		day 42	No
Primary	postprandial blood glucose (iAUC) (0-240 min)		day 84	No
Secondary	postprandial peak blood glucose (0-240 min)		day 1, day 42, day 84	No
Secondary	postprandial triglycerides (0-240 min)		day 1, day 42, day 84	Yes
Secondary	total cholesterol, HDL-cholesterol, LDL-cholesterol		day 1, day 42, day 84	No
Secondary	total protein, albumin, prealbumin		day 1, day 42, day 84	No
Secondary	HbA1c, HOMA-IR index		day 1, day 42, day 84	No
Secondary	c-peptide		day 1, day 84	No
Secondary	gastrointestinal tolerance		week 1, week 6, week 12	Yes
Secondary	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	No
Secondary	daily compliance	in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed.	day 1-84	No