NCT01208701

Brief Summary

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

September 19, 2010

Last Update Submit

August 19, 2015

Conditions

NephropathyCardiovascular DiseasesDiabetes Mellitus

Keywords

AtorvastatinL-NMMANONephrologyDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Fractional excretion of sodium

    5 days treatment

Secondary Outcomes (6)

  • Systolic blood pressure

    5 days

  • Plasma renin concentration

    5 days

  • Arterial stiffness

    5 days

  • Plasma angiotensin II concentration

    5 days

  • Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)

    5 days

  • +1 more secondary outcomes

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR
Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR
Drug: Unikalk

Interventions

AtorvastatinDRUG

Zarator, 80 mg pr day for 5 days

Also known as: Zarator
Atorvastatin
UnikalkDRUG

1 tablet Unikalk pr day for 5 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • minimum 40 years
  • Chronic Kidney disease
  • Estimated GFR (eGFR) between 30 and 90 ml/min
  • Diabetes Mellitus type II

You may not qualify if:

  • Nephrotic Syndrome
  • Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
  • Neoplastic disease
  • Alcohol abuse,
  • Drug abuse
  • Pregnancy or nursing
  • Blood donation within a month before examination
  • Hgb \< 6,0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

Location

Related Publications (2)

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

    PMID: 38018702DERIVED

  • Mose FH, Larsen T, Jensen JM, Hansen AB, Bech JN, Pedersen EB. Effect of atorvastatin on renal NO availability and tubular function in patients with stage II-III chronic kidney disease and type 2 diabetes. Scand J Clin Lab Invest. 2014 Jan;74(1):8-19. doi: 10.3109/00365513.2013.855942. Epub 2013 Nov 21.

    PMID: 24256611DERIVED

MeSH Terms

Conditions

Kidney DiseasesCardiovascular DiseasesDiabetes Mellitus

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Frank H Christensen, MD

    Department of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor chief physician

Study Record Dates

First Submitted

September 19, 2010

First Posted

September 24, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DK(1)