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

NCT ID: NCT00699426

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nexium + Yoghurt

Group Type ACTIVE_COMPARATOR

nexium

Intervention Type DRUG

40 mg once daily is tested together with Yoghurt

Nexium + Placebo

Group Type PLACEBO_COMPARATOR

nexium

Intervention Type DRUG

nexium and placebo are tested

Placebo+ Yoghurt

Group Type PLACEBO_COMPARATOR

Yoghurt

Intervention Type DIETARY_SUPPLEMENT

Yoghurt

placebo+placebo

Group Type PLACEBO_COMPARATOR

placebo+placebo

Intervention Type DRUG

placebo and placebo are tested.

Interventions

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nexium

40 mg once daily is tested together with Yoghurt

Intervention Type DRUG

nexium

nexium and placebo are tested

Intervention Type DRUG

Yoghurt

Yoghurt

Intervention Type DIETARY_SUPPLEMENT

placebo+placebo

placebo and placebo are tested.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Chr Hansen

INDUSTRY

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role collaborator

Lise Tarnow

OTHER

Sponsor Role lead

Responsible Party

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Lise Tarnow

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Allan A. Vaag, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Countries

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Denmark

References

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Hove KD, Brons C, Faerch 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.

Reference Type DERIVED
PMID: 23011351 (View on PubMed)

Other Identifiers

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EudraCT: 2007-00405237

Identifier Type: -

Identifier Source: org_study_id