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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544206
• Other study ID #: BK07
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2007
• Last updated: September 22, 2008
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• standard enteral feeding product
16 hrs daily x 5 days
• Diabetes specific feeding product
16 hrs daily for 5 days

Locations

Country	Name	City	State
United States	Segal Institute for Clinical Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean glucose level		24 hours	No
Secondary	fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin		24 hours	No