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

Sponsor:	Steno Diabetes Center
Collaborators:	Novo Nordisk Chr Hansen A/S Statens Serum Institut
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00699426

Purpose

To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.

Study Hypothesis:

Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
Probiotics changes the gut flora and bloodpressure
Probiotics causes a change in inflammation and thrombosis.

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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Sponsors and Collaborators

Steno Diabetes Center

Novo Nordisk

Chr Hansen A/S

Statens Serum Institut

Investigators

Principal Investigator:

Allan A. Vaag, MD, DMSc

Steno Diabetes Center

More Information

No publications provided

Responsible Party:	Allan A. Vaag, -
ClinicalTrials.gov Identifier:	NCT00699426 History of Changes
Other Study ID Numbers:	EudraCT: 2007-00405237
Study First Received:	June 16, 2008
Last Updated:	March 10, 2010
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 February 09, 2012