Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) - Tabular View

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Tracking Information

First Received Date ^†

October 10, 2008

Last Updated Date

December 18, 2008

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00771693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With NIDDM: a Placebo-Controlled Dose-Response Study With Insulin Aspart (Novorapid®)

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

Condition ^†

Type 2 Diabetes Mellitus
Postprandial Hyperglycemia

Intervention ^†

Drug: Insulin aspart (Novorapid®)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

up to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Paul Hjemdahl, MD, PhD

0046-8-51775293

paul.hjemdahl@ki.se

Location Countries ^†

Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00771693

Responsible Party

Prof. Paul Hjemdahl, Dept Medicine Solna, Clinical Pharmacology Unit, Karolinska Institute, Stockholm, Sweden

Secondary IDs ^††

Study Sponsor ^†

Karolinska Institutet

Collaborators ^††

Investigators ^†

Principal Investigator:

Paul Hjemdahl, MD, PhD

Department of Medicine, Clinical Pharmacology Unit, Karolinska institute, Stockhom, Sweden

Information Provided By

Karolinska Institutet

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.