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

Type 2 Diabetes Clinical Trial

— Nexium  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699426
• Other study ID #: EudraCT: 2007-00405237
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2008
• Last updated: August 31, 2012
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2012
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• nexium
40 mg once daily is tested together with Yoghurt
• nexium
nexium and placebo are tested

Dietary Supplement:
• Yoghurt
Yoghurt

Drug:
• placebo+placebo
placebo and placebo are tested.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Lise Tarnow	Chr Hansen A/S, Novo Nordisk A/S, Statens Serum Institut, Steno Diabetes Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin secretion		1 year	No
Secondary	blood pressure		1 year	No