The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System

NCT01116180

Type 1 Diabetes Hypoglycemia

COMPLETED NA

Recurrent Hypoglycaemia in Type 1 Diabetes

NCT01337362

Hypoglycaemia

COMPLETED NA

The Effects of Renal Denervation on Insulin Sensitivity

NCT01631370

Treatment Resistant Essential Hypertension Insulin Resistance

COMPLETED NA

Consequences of Hypoglycaemia on Cardiovascular and Inflammatory Responses

NCT03976271

Hypoglycemia Inflammatory Response Diabetes Mellitus, Type 1 +1 more

COMPLETED NA

Recurrent Hypoglycemia in Type 1 Diabetes (Aim 1)

NCT03410277

Diabetes Mellitus, Type 1

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoglycemia Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High RAS activity

10 healthy men were characterized by having high basal RAS activity.

Group Type EXPERIMENTAL

Human insulin

Intervention Type DRUG

Hyperinsulinaemic induced hypoglycaemia

Low RAS activity

10 healthy men were characterized by having either a low basal RAS activity.

Group Type EXPERIMENTAL

Human insulin

Intervention Type DRUG

Hyperinsulinaemic induced hypoglycaemia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Human insulin

Hyperinsulinaemic induced hypoglycaemia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes