Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Diabetes specific feeding product; Other: standard enteral feeding product

• Registration Number: NCT00544206
• Lead Sponsor: Abbott Nutrition

Brief Summary

To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-12
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-16
• Primary Completion: 2008-08
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-22
• Last Update Posted: 2008-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• signed and dated informed consent
• diagnosis of type 2 diabetes
• HbA1c between 7.0 and 9.0%
• 18 - 75 years of age
• currently receiving a standard enteral product
• anticipated duration on tube feeding at least one month
• 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
• anticipated life expectancy is more than or equal to 6 months
• free of infections
• no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose

Exclusion Criteria

• composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
• composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
• significant cardiovascular event less than or equal to 2 weeks prior to study entry
• major surgery less than or equal to 2 weeks prior to study entry
• pre-planned surgery during the study period
• active malignancy, including melanoma and excluding cutaneous malignancies
• severe dementia
• known allergies to medical grade adhesives and/or skin disinfectants
• taking octreotide
• chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
• participation in a concomitant trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
#1	Diabetes specific feeding product	Diabetes specific enteral feeding product
#2	standard enteral feeding product	Standard enteral feeding product

Primary Outcome Measures

Name	Time	Method
mean glucose level	24 hours

Secondary Outcome Measures

Name	Time	Method
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin	24 hours

Trial Locations

Locations (1)

Segal Institute for Clinical Research; 🇺🇸 Miami, Florida, United States