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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Netherlands
  • Haarlem, Netherlands, 2023 KT
    • Kennemer Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

50 subjects with T2DM and 50 nondiabetic individuals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with type 2 diabetes mellitus
Normoglycemic individuals; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KGINTDVR001