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Completed

NCT Number: NCT00742976

Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept of Endocrinology, Rigshospitalet

Copenhagen, København Ø, DK_2100, Denmark

About this study

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 hypothesize 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 blood glucose (except oral antidiabetics)
  • Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)
  • Clinical significant disease that may influence outcome ( cancer etc)

Treatment and study plan

Insulin Detemir; Insulin Insulatard

Drug

Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.

Insulin Detemir, Insulin Insulatard

Drug

Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.

Primary outcomes

  1. change in weight; change in extracellular volume

    Time frame: 17 weeks

Secondary outcomes

  1. sodium excretion in urine, 24 hour blood pressure, body composition change,urine osmolality, urine albumin excretion, GFR, HbA1c, Blood lipid profile, NT-proBNP, plasma Albumin, Plasma metanephrines, aldosterone, active renin, angiotensin II

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients

Acronym: Le-Na

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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