Comparison of Nutritional Products for People With Type 2 Diabetes
1 other identifier
interventional
58
1 country
3
Brief Summary
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Nov 2008
Shorter than P25 for phase_3 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 23, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 30, 2010
March 1, 2010
3 months
November 23, 2008
July 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Three crossover periods
Secondary Outcomes (1)
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Three crossover periods
Study Arms (3)
standard nutritional product
ACTIVE COMPARATORStandard nutritional product not specific for diabetes
diabetes specific product
ACTIVE COMPARATORDiabetes specific nutritional product
Experimental diabetes specific product
EXPERIMENTALDiabetes specific experimental nutritional product
Interventions
once during crossover
Eligibility Criteria
You may qualify if:
- Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- Subject is between 18 and 75 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing a method of birth control.
- Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2.
- If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
You may not qualify if:
- Subject uses exogenous insulin for glucose control.
- Subject states that he/she has type 1 diabetes.
- Subject states that he/she has a history of diabetic ketoacidosis.
- Subject takes an alpha-glucosidase inhibitor.
- Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a history of severe gastroparesis.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- Subject states that he/she has clotting or bleeding disorders.
- Subject is known to be allergic or intolerant to any ingredient found in the study products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (3)
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jennifer Williams, MS
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
November 23, 2008
First Posted
November 25, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2009
Study Completion
July 1, 2009
Last Updated
July 30, 2010
Record last verified: 2010-03