Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-insulin-dependent Diabetes Mellitus (NIDDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771693
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : November 5, 2010
Information provided by:
Karolinska Institutet

October 10, 2008
October 13, 2008
November 5, 2010
May 2007
August 2010   (Final data collection date for primary outcome measure)
  • To evaluate if platelet activation following a carbohydrate rich meal is related to the post-prandial hyperglycemia, and thus can be attenuated by premeal insulin treatment in patients with T2DM. [ Time Frame: 90 minutes after the meal ]
  • Co- primary platelet response variables: U46619 stimulated platelet P- selectin activation, platelet-leukocyte aggregation, platelet-platelet aggregates and platelet-monocyte aggregates. [ Time Frame: After completion of the study in 20 patients ]
Same as current
Complete list of historical versions of study NCT00771693 on Archive Site
To elucidate if short-term lowering of blood glucose by insulin infusion (pretreatment standardization of blood glucose) reduces platelet activity in patients with T2DM. [ Time Frame: After completion of the glucose normalization (before the meal) ]
Same as current
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Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-insulin-dependent Diabetes Mellitus (NIDDM)
Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With NIDDM: a Placebo-controlled Dose-response Study With Insulin Aspart (Novorapid®)

The postprandial phase in diabetic patients is characterized by a rapid increase in blood glucose levels, increase in platelet aggregation, LDL oxidation and over production of thrombin.

The aim of the study is to determine whether meal induced platelet activation is related to post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with rapidly acting insulin in patients with T2DM.

Each patient is admitted in the fasting state, on 3 different occasions . Blood glucose levels are normalized using intravenous infusion of insulin aspart , to a blood glucose level of 6-7 mmol/l. 15 minutes after normalization ,and right before a standardized meal, the patient is given a subcutaneous injection of insulin aspart 0.1 U/kg, 0.2 U/kg or placebo. The order of injections in the cross over study is randomized and blinded to the patient and to the investigators. The patient eats the meal and is followed up for 90 minutes after completion of the meal.

Blood tests for platelet function and other parameters are taken at 3 main points: 1. before glucose normalization.

2. 15 minutes after glucose normalization, and right before the meal. 3. 90 minutes after the meal.

Platelet function is evaluated by flow cytometry in whole blood (P- Selectin expression, Fibrinogen binding,aggregate formation: platelet- leukocyte, platelet-platelet, platelet-monocyte). Agonists that are used for platelet activation in flow cytometry are the thromboxane analogue U46619, ADP, and a collagen peptide that activates GPVI. Platelet adhesion is measured by the IMPACT cone and platelet analyser.

Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Type 2 Diabetes Mellitus
  • Postprandial Hyperglycemia
Drug: Insulin aspart (Novorapid®)
a cross-over study with subcutaneous injection of insulin aspart 0.1U/kg, 0.2u/kg or placebo, before the meal, on 3 different occasions.
Other Name: NovoRapid (Novo-Nordisk)
Not Provided
Spectre G, Östenson CG, Li N, Hjemdahl P. Postprandial platelet activation is related to postprandial plasma insulin rather than glucose in patients with type 2 diabetes. Diabetes. 2012 Sep;61(9):2380-4. doi: 10.2337/db11-1806. Epub 2012 Jun 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type II Diabetes Mellitus.
  • Antecubital forearm veins allowing technically good sampling for platelet studies.
  • HbA1c 6-9 % (Mono-S method).
  • Below 70 years

Exclusion Criteria:

  • History of a cardiovascular disease; Ischemic heart disease, Stroke, Peripheral vascular disease.
  • Acute or chronic renal or liver disease
  • Contraindication to insulin treatment
  • Treatment with Glitazones, Sulphonylurea, antiplatelet drugs,
  • Thrombocytopenia <150 X109/l.
Sexes Eligible for Study: All
up to 70 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT number 2006-007031-27
Not Provided
Not Provided
Prof. Paul Hjemdahl, Dept Medicine Solna, Clinical Pharmacology Unit, Karolinska Institute, Stockholm, Sweden
Karolinska Institutet
Not Provided
Principal Investigator: Paul Hjemdahl, MD, PhD Department of Medicine, Clinical Pharmacology Unit, Karolinska institute, Stockhom, Sweden
Karolinska Institutet
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP