NCT00771693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2007

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

4.2 years

First QC Date

October 10, 2008

Last Update Submit

May 24, 2022

Conditions

Type 2 Diabetes MellitusPostprandial Hyperglycemia

Keywords

NIDDMPlatelet ActivationPostprandial hyperglycemiainsulin

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    After completion of the study in 20 patients

Secondary Outcomes (1)

  • To elucidate if short-term lowering of blood glucose by insulin infusion (pretreatment standardization of blood glucose) reduces platelet activity in patients with T2DM.

    After completion of the glucose normalization (before the meal)

Interventions

Insulin aspart (Novorapid®)DRUG

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.

Also known as: NovoRapid (Novo-Nordisk)

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.

Stockholm, SE 171 76, Sweden

Location

Related Publications (1)

  • Spectre G, Ostenson 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.

    PMID: 22688337DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperglycemiaInsulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Paul Hjemdahl, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

May 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

SE(1)