NCT00520065

Brief Summary

Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes. Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 4, 2008

Status Verified

August 1, 2007

Enrollment Period

2 months

First QC Date

August 21, 2007

Last Update Submit

July 2, 2008

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Positive area under the curve (AUC) for plasma glucose and mean glucose level

    240 minutes

Secondary Outcomes (1)

  • Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration

    240 minutes

Study Arms (2)

#1

EXPERIMENTAL

Diabetes specific enteral product

Other: Diabetes specific enteral product

#2

ACTIVE COMPARATOR

Standard enteral feeding

Other: enteral nutritional formula

Interventions

enteral nutritional formulaOTHER

Meal glucose tolerance test

#2
Diabetes specific enteral productOTHER

Meal Glucose tolerance test

#1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent form
  • Type 2 diabetes
  • to 75 years of age
  • Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
  • If female is of childbearing potential, is practicing birth control
  • BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
  • Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit

You may not qualify if:

  • Uses exogenous insulin for glucose control
  • Type 1 diabetes
  • History of diabetic ketoacidosis
  • Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
  • Active malignancy
  • Significant cardiovascular event less than 12 weeks prior to study entry
  • End stage organ failure or is status post organ transplant
  • Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
  • Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
  • Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
  • Fainted or experienced other adverse reactions in response to blood collection prior to this study
  • Has clotting or bleeding disorders
  • Allergic or intolerant to any ingredient found in the study products
  • Participant in a concomitant trial that conflicts with this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provident Clinical Research and Consulting, Inc.

Bloomington, Indiana, 47403, United States

Location

Related Publications (1)

  • Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.

    PMID: 20470226DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kevin C. Maki, PhD

    Provident Clinical Research and Consulting, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

July 4, 2008

Record last verified: 2007-08

Locations

US(1)