Status:
COMPLETED
The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Lead Sponsor:
Lise Tarnow
Collaborating Sponsors:
Novo Nordisk A/S
Chr Hansen
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00699426
Start Date
June 1 2008
End Date
June 1 2009
Last Update
September 3 2012
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