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

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk
Chr Hansen A/S
Statens Serum Institut
Steno Diabetes Center
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00699426
First received: June 16, 2008
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Drug: nexium
Dietary Supplement: Yoghurt
Drug: placebo+placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nexium + Yoghurt Drug: nexium
40 mg once daily is tested together with Yoghurt
Other Name: Nexium
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699426

Sponsors and Collaborators
Lise Tarnow
Novo Nordisk
Chr Hansen A/S
Statens Serum Institut
Steno Diabetes Center
Investigators
Principal Investigator: Allan A. Vaag, MD, DMSc Steno Diabetes Center
  More Information

No publications provided by Steno Diabetes Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT00699426     History of Changes
Other Study ID Numbers: EudraCT: 2007-00405237
Study First Received: June 16, 2008
Last Updated: August 31, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013