Clinical Trials Logo
  1. Home
  2. Healthy Subjects
  3. NCT00678522
  4. Details
NCT00678522 Clinical Trial

The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes

Healthy Subjects Clinical Trial

Official title:
The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00678522
Other study ID # MED.RES.HOS.2006.04.LP
Secondary ID
Status Completed
Phase Phase 4
First received May 13, 2008
Last updated May 14, 2008
Start date September 2007
Est. completion date May 2008

Study information
Verified date May 2008
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type II diabetes, not in treatment with insulin.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

1. Age: 40-70 yrs

2. estimated GFR between 30 and 90 ml/min

3. BMI<35

4. Fertile women had to use oral contraceptives or IUD

5. HbA1c< 10%

6. Urine-albumin<1,5 g/l

Exclusion Criteria:

1. Treatment with insulin

2. Cerobrovascular insult or other disease of the brain

3. Insufficiency of the heart or lungs

4. Liverdisease with ALAT > 200 U/L

5. hemoglobin < 7,0 mmol/l

6. Cancer

7. Alcohol abuse

8. Medical treatment with psycopharmaca or/and analgetics

9. Pregnancy and breast feeding, 10 blood donation one month before the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
80 mg atorvastatin daily on two following days

Locations
Country Name City State
Denmark Department of Medical Research, Holstebro Hospital Holstebro
Denmark Medical Reseach, Holstebro Hospital Holstebro

Sponsors (2)
Lead Sponsor Collaborator
Regional Hospital Holstebro Medical Research

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance. 6 months
Secondary AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR. 6 months
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1