Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals

NCT ID: NCT02031341

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus. It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle interstitium plays a role in this process.

We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes mellitus.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with type 2 diabetes mellitus

No interventions assigned to this group

Normoglycemic individuals

Control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* hemodynamically stable with a systolic blood pressure \> 100 mmHg
* medical need to undergo a CAG procedure as determined by cardiologist


* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \< 7.0 mmol/L and HbA1C \< 6.5% (= \< 48 mmol/mol)


* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \> 7.0 mmol/L, or HbA1C \> 6.5 (= \> 48 mmol/mol) or known T2DM

Exclusion Criteria

* ongoing myocardial infarction as determined from elevated cardiac markers
* participation in an investigational trial within 90 days prior to present study
* donation of blood (\> 100 mL) within 90 days prior to present study
* serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
* Use or recent use (within 3 months of study participation) of oral glucocorticoids


\- known T2DM/use of glucose-lowering medication


\- treatment with insulin preparations
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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D van Raalte

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kennemer Gasthuis

Haarlem, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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KGINTDVR001

Identifier Type: -

Identifier Source: org_study_id