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

Tracking Information

First Received Date ^ICMJE

June 16, 2008

Last Updated Date

August 31, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

insulin secretion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699426 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: nexium
40 mg once daily is tested together with Yoghurt

Other Name: Nexium
Drug: nexium
nexium and placebo are tested
Dietary Supplement: Yoghurt
Yoghurt
Drug: placebo+placebo
placebo and placebo are tested.

Study Arm (s)

Active Comparator: Nexium + Yoghurt
Intervention: Drug: nexium
Placebo Comparator: Nexium + Placebo
Intervention: Drug: nexium
Placebo Comparator: Placebo+ Yoghurt
Intervention: Dietary Supplement: Yoghurt
Placebo Comparator: placebo+placebo
Intervention: Drug: placebo+placebo

Publications *

Hove KD, Brøns C, Færch K, Lund SS, Petersen JS, Karlsen AE, Rossing P, Rehfeld JF, Vaag A. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes: a randomised double-blind prospective placebo-controlled study. Diabetologia. 2013 Jan;56(1):22-30. doi: 10.1007/s00125-012-2714-y. Epub 2012 Sep 26.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00699426

Other Study ID Numbers ^ICMJE

EudraCT: 2007-00405237

Has Data Monitoring Committee

Yes

Responsible Party

Lise Tarnow, Steno Diabetes Center

Study Sponsor ^ICMJE

Lise Tarnow

Collaborators ^ICMJE

Novo Nordisk
Chr Hansen A/S
Statens Serum Institut
Steno Diabetes Center

Investigators ^ICMJE

Principal Investigator:

Allan A. Vaag, MD, DMSc

Steno Diabetes Center

Information Provided By

Steno Diabetes Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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