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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00699426

Acronym

Nexium

Enrollment

Registered

2008-06-18

Start date

2008-06-30

Completion date

2009-06-30

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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.

Interventions

DRUGnexium

40 mg once daily is tested together with Yoghurt

DIETARY_SUPPLEMENTYoghurt

Yoghurt

DRUGplacebo+placebo

placebo and placebo are tested.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
insulin secretion	1 year

Secondary

Measure	Time frame
blood pressure	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026