Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Karolinska Institutet |
---|---|
Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00771693 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus Postprandial Hyperglycemia |
Drug: Insulin aspart (Novorapid®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study |
Official Title: | Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With NIDDM: a Placebo-Controlled Dose-Response Study With Insulin Aspart (Novorapid®) |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Hjemdahl, MD, PhD | 0046-8-51775293 | paul.hjemdahl@ki.se |
Sweden | |
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna. | Recruiting |
Stockholm, Sweden, SE 171 76 | |
Contact: Paul Hjemdahl, MD, PhD 0046-8-51775293 paul.hjemdahl@ki.se | |
Principal Investigator: Paul Hjemdahl, MD, PhD |
Principal Investigator: | Paul Hjemdahl, MD, PhD | Department of Medicine, Clinical Pharmacology Unit, Karolinska institute, Stockhom, Sweden |
Responsible Party: | Dept Medicine Solna, Clinical Pharmacology Unit, Karolinska Institute, Stockholm, Sweden ( Prof. Paul Hjemdahl ) |
Study ID Numbers: | EudraCT number 2006-007031-27 |
Study First Received: | October 10, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00771693 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
NIDDM Platelet Activation Postprandial hyperglycemia insulin |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Physiological Effects of Drugs Diabetes Mellitus, Type 2 Insulin, Asp(B28)- |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |