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

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT02031341

KGINTDVR001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

Patients with type 2 diabetes mellitus

Normoglycemic individuals

Description:

Control group