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

This study is currently recruiting participants.

Verified by Steno Diabetes Center, June 2008

First Received: June 16, 2008 Last Updated: June 17, 2008 History of Changes

Sponsors and Collaborators:	Steno Diabetes Center Novo Nordisk Chr-Hansen 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

MedlinePlus related topics: Diabetes

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
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.

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 ]

Estimated Enrollment:	36
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nexium + Yoghurt: Active Comparator	Drug: nexium 40 mg once daily is tested together with Yoghurt
Nexium + Placebo: Placebo Comparator	Drug: nexium nexium and placebo are tested
Placebo+ Yoghurt: Placebo Comparator	Dietary Supplement: Yoghurt Yoghurt
placebo+placebo: Placebo Comparator	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
Males and females between 40 and 70 years
Fasting C-peptide> 0,3 pmol/l within the last year
HbA1c between 7-10 within the last year
Blood pressur between 130-170/95 mm Hg

Exclusion Criteria:

Kidney disease
Macroalb.
Heart failure(NYHA class lll or lV)
Alcohol abuse
Drug abuse
Other acute or chronic disease
C-peptide< 0,3
Medicin interaction
PPI or other medications for ulcus diseases
Treatment with steroid or other hormone treatment
Bloodpressure>170/105 mmHg
Bloodpressure<130/85 mmHg
Neutropenia or anemia
Treatment with warfarin or other coumarin derivations
Pregnant or breestfeeding women
Allergy to medication used in the study
Lever disease

Contacts and Locations

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

Contacts

Contact: Allan A Vaag, MD,DMSC	45-4443-9214	avaa@steno.dk
Contact: Karin D Hove, MD	45-3075-9366	khov@steno.dk

Locations

Denmark, Gentofte,
Steno Diabetes Center	Recruiting
Copenhagen, Gentofte,, Denmark, 2820
Principal Investigator: Allan A Vaag, MD, DMSc

Sponsors and Collaborators

Steno Diabetes Center

Novo Nordisk

Chr-Hansen

Statens Serum Institut

Investigators

Principal Investigator:

Allan A. Vaag, MD, DMSc

Steno Diabetes Center

More Information

No publications provided

Responsible Party:	- ( Allan A. Vaag )
Study ID Numbers:	EudraCT: 2007-00405237
Study First Received:	June 16, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00699426 History of Changes
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Medicines Agency; Denmark: Danish Dataprotection Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Omeprazole
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Diabetes Mellitus, Type 2
Gastrointestinal Agents

Diabetes Mellitus
Omeprazole
Endocrine System Diseases
Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009