The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Information source: Steno Diabetes Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: nexium (Drug); nexium (Drug); Yoghurt (Dietary Supplement); placebo+placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Steno Diabetes Center Official(s) and/or principal investigator(s):
Allan A. Vaag, MD, DMSc, Principal Investigator, Affiliation: Steno Diabetes Center
Overall contact:
Allan A Vaag, MD,DMSC, Phone: 45-4443-9214, Email: avaa@steno.dk
Summary
To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk
factors on type 2 diabetic patients.
Study Hypothesis:
1. Nexium causes an increased gastrin secretion that increases the insulin secretion and
thereby a reduction of HbA1c
2. Probiotics changes the gut flora and bloodpressure
3. Probiotics causes a change in inflammation and thrombosis.
Clinical Details
Official title: The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-Blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: insulin secretion
Secondary outcome: blood pressure
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 diabetes
- Males and females between 40 and 70 years
- Fasting C-peptide> 0,3 pmol/l within the last year
- HbA1c between 7-10 within the last year
- Blood pressur between 130-170/95 mm Hg
Exclusion Criteria:
- Kidney disease
- Macroalb.
- Heart failure(NYHA class lll or lV)
- Alcohol abuse
- Drug abuse
- Other acute or chronic disease
- C-peptide< 0,3
- Medicin interaction
- PPI or other medications for ulcus diseases
- Treatment with steroid or other hormone treatment
- Bloodpressure>170/105 mmHg
- Bloodpressure<130/85 mmHg
- Neutropenia or anemia
- Treatment with warfarin or other coumarin derivations
- Pregnant or breestfeeding women
- Allergy to medication used in the study
- Lever disease
Locations and Contacts
Allan A Vaag, MD,DMSC, Phone: 45-4443-9214, Email: avaa@steno.dk
Steno Diabetes Center, Copenhagen, Gentofte, 2820, Denmark; Recruiting
Allan A Vaag, MD, DMSc, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: June 2009
Last updated: June 17, 2008
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