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Trial NCT00742976

Resource URI: http://static.linkedct.org/resource/trials/NCT00742976
linkedct:acronym Le-Na
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/1010>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/14518>
linkedct:brief_title Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients
linkedct:condition <http://static.linkedct.org/resource/condition/13932>
linkedct:condition <http://static.linkedct.org/resource/condition/3830>
linkedct:criteria Inclusion Criteria: - Type 2 diabetes according to WHO 1999 criteria for at least 3 month - Insulin treated for at least 1 month - BMI 25-40 - Age 18-80 - Hb1Ac < 10% Exclusion Criteria: - Hypertension not well regulated - Serum creatinine > 130 micromol/l - Non-diabetic kidney disease - Disease that may cause invalid hgbA1c measurement - Substance abuse - Recent use of Detemir - Pregnancy or risk of becoming pregnant - Any condition that may disturb protocol adherence (language barrier etc) urinary albumin > 30 mg/24hours ( before screening) - Use of drugs that may influence bloodglucose (except oral antidiabetics) - Use of drugs that may influence sodium balance (diuretics etc) - Clinical significant disease that may influence outcome ( cancer etc)
linkedct:description Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients with diabetes have increased total body sodium and increased extracellular volume. We hypothethesize that part of the weight gain seen is due to increase in extracellular volume and that the lesser weight gain seen in patients treated with Detemir is due to an lesser increase in extracellular volume. We believe that the cause of this difference is the different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with other insulins, and therefore less increase in extracellular volume. We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2009
linkedct:enrollment 24 (xsd:int)
linkedct:firstreceived_date August 27, 2008
linkedct:has_dmc Yes
linkedct:id NCT00742976
linkedct:intervention <http://static.linkedct.org/resource/intervention/35904>
linkedct:intervention <http://static.linkedct.org/resource/intervention/37687>
rdfs:label Trial NCT00742976
linkedct:lastchanged_date August 27, 2008
linkedct:lead_sponsor_agency Rigshospitalet, Denmark
linkedct:location <http://static.linkedct.org/resource/location/269217>
linkedct:nct_id NCT00742976
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients
linkedct:org_study_id EudraCT 2008-001602-16
linkedct:overall_contact_email tonny.jensen@rh.regionh.dk
linkedct:overall_contact_last_name Tonny Jensen, M.D. DMSci
linkedct:overall_contact_phone +45 35455218
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59100>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/655>
linkedct:oversight <http://static.linkedct.org/resource/oversight/660>
linkedct:oversight <http://static.linkedct.org/resource/oversight/716>
foaf:page <http://clinicaltrials.gov/show/NCT00742976>
linkedct:phase Phase 4
linkedct:primary_completion_date January 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/33863>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99536>
linkedct:source Rigshospitalet, Denmark
linkedct:start_date June 2008
linkedct:study_design Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.
rdf:type linkedct:trials
linkedct:verification_date June 2008