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

Type 2 Diabetes Mellitus Clinical Trial

— PEAKS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031341
• Other study ID #: KGINTDVR001
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: December 8, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion criteria for all participants:

• written informed consent

• hemodynamically stable with a systolic blood pressure > 100 mmHg

• medical need to undergo a CAG procedure as determined by cardiologist

Exclusion criteria for all participants:

• 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

Inclusion criteria for non-diabetic individuals:

• 30 years = age = 80 years (extremes included)

• fasting glucose level of < 7.0 mmol/L and HbA1C < 6.5% (= < 48 mmol/mol)

Exclusion criteria for non-diabetic individuals:

• known T2DM/use of glucose-lowering medication

Inclusion criteria for T2DM patients:

• 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 for T2DM patients:

• treatment with insulin preparations

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Netherlands	Kennemer Gasthuis	Haarlem

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fore-arm insulin uptake measured as ([A]-[V]) x F in pmol/min where A = arterial insulin concentrations, V= venous insulin concentrations, F = fore arm plasma flow;	During a single measure (thus cross-sectional) the primary endpoint will be measured.	Baseline	No