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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38749
Enrollment
100
Registered
2013-12-16
Start date
2014-03-10
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 2 diabetes mellitus

Interventions

None listed

Sponsors

Kennemer Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for all participants: - written informed consent - hemodynamically stable with a systolic blood pressure > 100 mmHg Inclusion criteria for non-diabetic individuals: - 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

Exclusion criteria: 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 Exclusion criteria for non-diabetic individuals: - known T2DM/use of glucose-lowering medication Exclusion criteria for T2DM patients: - treatment with insulin preparations

Design outcomes

Primary

MeasureTime frame
Primary objective: Is insulin uptake impaired in T2DM patients as compared to non-diabetic individuals, both in the fasted state and during postprandial hyperinsulinemia? (Specific parameters that will be calculated are explained in the study protocol page 7).

Secondary

MeasureTime frame
Secondary objectives: what are determinants of insulin uptake in T2DM patients and in non-diabetic controls (i.e. metabolic parameters known to affect insulin sensitivity, and hemodynamic parameters)? Are glucose uptake and insulin uptake differentially related in T2DM patients as compared to non-diabetics? Does insulin uptake associate with measures of glycemic control such as fasting or postprandial glucose levels and A1C?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)