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

NCT00699426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-09-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

nexium

40 mg once daily is tested together with Yoghurt

DRUG

nexium

nexium and placebo are tested

DIETARY_SUPPLEMENT

Yoghurt

Yoghurt

DRUG

placebo+placebo

placebo and placebo are tested.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Chr Hansen

    collaborator INDUSTRY

  • Statens Serum Institut

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Lise Tarnow

    lead OTHER

Principal Investigators

  • Allan A. Vaag, MD, DMSc · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00699426 on ClinicalTrials.gov