Consequences of Hypoglycaemia on Cardiovascular and Inflammatory Responses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2021-03-31

Brief Summary

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People with Type 1 diabetes (T1DM), type 2 diabetes (T2DM) and healthy volunteers will undergo a hypoglycaemic clamp to to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses.

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Detailed Description

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Objectives: The overall aim of the present study is to investigate the effect of hypoglycaemia on cardiovascular and inflammatory responses, molecular mechanisms and epigenetic profiles in various groups of people with diabetes type 1, type 2 and healthy volunteers.

Study design: Intervention study

Intervention: All subjects will undergo a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp (nadir 2.8 mmol/L), during and after which blood and urine will be sampled for further examination for up to one week.

Conditions

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Hypoglycemia Inflammatory Response Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

All subjects will undergo a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp (nadir 2.8 mmol/L), during and after which blood and urine will be sampled for further examination for up to one week.

Study Groups

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T1DM poor glycaemic control

patients with type 1 diabetes and poor glycaemic control (HbA1c \>8% / \>64 mmol/mol will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

T1DM impaired awareness

patients with type 1 diabetes and impaired awareness of hypoglycaemia will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

T1DM Normal awareness

patients with type 1 diabetes and normal awareness of hypoglycaemia will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

T2DM + Insulin

patients with type 2 diabetes with insulin treatment for at least 1 year will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

Healthy control T2DM

healthy controls without diabetes and age, gender and BMI matched with diabetes type 2 participants will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

Healthy control T1DM

Healthy controls without diabetes and age, gender and BMI matched with diabetes type 1 participants will undergo hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Group Type ACTIVE_COMPARATOR

hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

Intervention Type PROCEDURE

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

Interventions

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hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp

For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.

Intervention Type PROCEDURE

Other Intervention Names

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hypoglycaemic clamp

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent
* Must be able to speak and read Danish (for Hillerød-site) and Dutch (for Nijmegen-site)
* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump) (except for group 5)
* Body-Mass Index: 19-40 kg/m2
* Age ≥18 years, ≤ 80 years
* Blood pressure: \<140/90 mmHg
* Duration of diabetes \> 1 year (except for group 5)
* HbA1c \< 100 mmol/mol

Group specific

* Group 1: HbA1c \>64 mmol/mol
* Group 2: impaired awareness of hypoglycaemia (IAH) as assessed by a score of ≥3 on the modified Clarke questionnaire, ≥4 on the Gold questionnaire and a positive score on the Pedersen-Bjergaard questionnaire.
* Group 3: normal awareness of hypoglycaemia (NAH) as assessed by a score of \<3 on the modified Clarke questionnaire, \<4 on the Gold questionnaire and a negative score on the Pedersen-Bjergaard.
* Group 4: Insulin treatment for at least 1 year
* Group 5/6: HbA1c \<42 mmol/mol

Exclusion Criteria

* \- Severe medical or psychological conditions interfering with the perception of hypoglycaemia other than IAH such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
* Use of immune-modifying drugs or antibiotics
* Treatment with glucose-modifying (other than insulin, SGLT-2 inhibitors and metformin) agents (e.g. prednisolon)
* Use of anti-depressive drugs
* Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
* Use of statins (e.g. stop statins \>2 weeks before performing blood sampling. This can be safely done in the context of primary prevention)
* Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease)
* Auto-inflammatory or auto-immune diseases
* Any infection in past three months
* Previous vaccination in the past three months
* Laser coagulation for proliferative retinopathy in the past six months
* Proliferative retinopathy
* Diabetic nephropathy as reflected by an albumin-creatinine ratio ˃ 30 mg/gor an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
* History of pancreatitis (acute or chronic) or pancreatic cancer

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes