The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Information source: Steno Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed
Sponsored by: Lise Tarnow Official(s) and/or principal investigator(s):
Allan A. Vaag, MD, DMSc, Principal Investigator, Affiliation: Steno Diabetes Center
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 (WHO criteria) treated with metformin and/or sulfonylureas or diet
- Males and females between 40 and 70 years
- HbA1c between 6,0-10,0
- Diabetes duration > 1 year
Exclusion Criteria:
- Kidney disease (s-creatinine above the upper limit of normal range).
- Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).
- Macroalbuminuria (urinary albumin excretion of > 300 mg/day).
- Heart failure(NYHA class lll or lV)
- Severe neuropathy (symptoms + vibration perception threshold > 50 measured by
biothesiometer.)
- Neutropenia (neutrophil count<2. 0x10/l) or anemia (hemoglobin<8mM for men or <7mM for
women.
- Alcohol abuse
- Drug abuse
- Severe organic or metabolic diseases including cancer
- C-peptide< 0,3 pmol/l
- Medicine interaction
- Treatment with insulin
- PPI or other medications for ulcus diseases
- Treatment with warfarin or other coumarin derivations
- Pregnant or breastfeeding women
- Allergy to medication used in the study
- Participants may not participate in another clinical intervention trial
Locations and Contacts
Additional Information
Starting date: June 2008
Last updated: August 31, 2012
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