CClinicalTrials.gg
CompletedNCT00540488Updated Oct 15, 2007

Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

A Phase 3 interventional study of Adult enteral formula in Diabetes Mellitus Type 2, sponsored by Abbott Nutrition. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-15.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 54 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All

Inclusion criteria

  • signed and dated informed consent
  • 18-75 years of age
  • history of type 2 diabetes
  • males and non-pregnant, non-lactating females

Exclusion criteria

Exclusion Criteria:

  • subject uses insulin for glucose control
  • significant cardiovascular event \<12 weeks prior to study entry
  • active malignancies
  • history of end stage renal disease
  • history of organ transplant
  • current hepatic disease
  • intervention for HIB
  • takes niacin
  • history of gastroparesis
  • active disease that may interfere with nutrient intake
  • allergy or intolerance to ingredients in the study products
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Interventions

  • OtherAdult enteral formula
06

What researchers measure

Primary outcomes

  1. Adjusted area under the curve (adj-AUC) of glucose response

    Time frame: 0-240 minutes

Secondary outcomes

  1. Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance

    Time frame: 0 - 240 minutes

07

Study locations

2 sites
  • Protocare Trials, Chicago Center for Clinical Research
    Chicago, Illinois 60610, United States
  • Medical University of South Carolina
    Charleston, North Carolina 29425, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00540488
Lead sponsor
Abbott Nutrition
First posted
Oct 8, 2007
Start date
Aug 2002
Last update
Oct 15, 2007

Study contacts

Carolyn Alish, PhD
study chair · Abbott Nutrition
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion