NCT00699426

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. 1.Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
  2. 2.Probiotics changes the gut flora and bloodpressure
  3. 3.Probiotics causes a change in inflammation and thrombosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

June 16, 2008

Last Update Submit

August 31, 2012

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • insulin secretion

    1 year

Secondary Outcomes (1)

  • blood pressure

    1 year

Study Arms (4)

Nexium + Yoghurt

ACTIVE COMPARATOR
Drug: nexium

Nexium + Placebo

PLACEBO COMPARATOR
Drug: nexium

Placebo+ Yoghurt

PLACEBO COMPARATOR
Dietary Supplement: Yoghurt

placebo+placebo

PLACEBO COMPARATOR
Drug: placebo+placebo

Interventions

nexiumDRUG

40 mg once daily is tested together with Yoghurt

Nexium + Yoghurt
YoghurtDIETARY_SUPPLEMENT

Yoghurt

Placebo+ Yoghurt
placebo+placeboDRUG

placebo and placebo are tested.

placebo+placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23011351DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

EsomeprazoleYogurtPlacebo Effect

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and BeveragesEffect Modifier, EpidemiologicEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Allan A. Vaag, MD, DMSc

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 3, 2012

Record last verified: 2012-08