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OpenTrials
Completed

NCT Number: NCT02031341

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kennemer Gasthuis

Haarlem, 2023 KT, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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;

    Time frame: Baseline

    During a single measure (thus cross-sectional) the primary endpoint will be measured.

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: PEAKS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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