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

NCT02031341 | Completed

• 1 other identifier: KGINTDVR001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with type 2 diabetes mellitus

Normoglycemic individuals

Control group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 subjects with T2DM and 50 nondiabetic individuals

You may qualify if:

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

You may not qualify if:

• 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
• years ≤ age ≤ 80 years (extremes included)
• fasting glucose level of \< 7.0 mmol/L and HbA1C \< 6.5% (= \< 48 mmol/mol)
• \- known T2DM/use of glucose-lowering medication
• years ≤ age ≤ 80 years (extremes included)
• fasting glucose level of \> 7.0 mmol/L, or HbA1C \> 6.5 (= \> 48 mmol/mol) or known T2DM
• \- treatment with insulin preparations

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Kennemer Gasthuis

Haarlem, 2023 KT, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

NL (1)