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The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes (Nexium)

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ClinicalTrials.gov Identifier: NCT00699426
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : September 3, 2012
Sponsor:
Collaborators:
Novo Nordisk A/S
Chr Hansen
Statens Serum Institut
Steno Diabetes Center Copenhagen
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Copenhagen

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: nexium Dietary Supplement: Yoghurt Drug: placebo+placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nexium + Yoghurt Drug: nexium
40 mg once daily is tested together with Yoghurt
Placebo Comparator: Nexium + Placebo Drug: nexium
nexium and placebo are tested
Placebo Comparator: Placebo+ Yoghurt Dietary Supplement: Yoghurt
Yoghurt
Placebo Comparator: placebo+placebo Drug: placebo+placebo
placebo and placebo are tested.


Outcome Measures
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Primary Outcome Measures :
  1. insulin secretion [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699426


Sponsors and Collaborators
Lise Tarnow
Novo Nordisk A/S
Chr Hansen
Statens Serum Institut
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Allan A. Vaag, MD, DMSc Steno Diabetes Center Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lise Tarnow, professor, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT00699426    
Other Study ID Numbers: EudraCT: 2007-00405237
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Esomeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action