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 A/S
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699426

Sponsors and Collaborators
Lise Tarnow
Novo Nordisk A/S
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014