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

August 31, 2012 updated by: Lise Tarnow

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nexium + Yoghurt
Drug: nexium
40 mg once daily is tested together with Yoghurt
Drug: nexium
nexium and placebo are tested
Placebo Comparator: Nexium + Placebo
Drug: nexium
40 mg once daily is tested together with Yoghurt
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin secretion
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lise Tarnow

Collaborators

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

Investigators

  • Principal Investigator: Allan A. Vaag, MD, DMSc, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT: 2007-00405237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on nexium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe