Acute effects of inorganic nitrate on brain insulin-sensitivity in abdominally obese me

Completed

• Conditions: insulin resistance; Metabolic syndrome; 10018424

• Registration Number: NL-OMON49758
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Men
- Aged between 18 - 60 years
- Waist circumference minimal 102 cm (abdominally obese)
- Fasting plasma glucose * 7.0 mmol/L
- Fasting serum total cholesterol * 8.0 mmol/L
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of
the study, during the study and for 4 weeks after completion of the study
- Willingness not to use antibacterial mouth wash or toothpaste, chewing-gum
and tongue-scraping a week before the study
- No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria

- Women
- Left-handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of products or dietary supplements known to interfere with the main
outcomes as judged by the principal investigators
- Use medication to treat blood pressure, lipid or glucose metabolism
- Pharmacological treatment advised based on the Dutch general practitioners
association (NHG) for cardiovascular risk management.
- Use of an investigational product within another biomedical intervention
trial within the previous 1-month
- Severe medical conditions that might interfere with the study, such as
epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive
pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and
rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or
cardiovascular event, such as an acute myocardial infarction or cerebrovascular
accident
- Specific contra-indications for MRI imaging, including pacemakers,
surgical clips/material in body, metal splinters in eye, claustrophobia, or
tattoos in the facial area, such as permanent make-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the acute effect of inorganic nitrate as compared with<br /><br>placebo on the acute effect of inorganic nitrate as compared with placebo on<br /><br>brain insulin-sensitivity, as assessed by the gray-matter CBF response to<br /><br>intranasally administered insulin using MRI ASL. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the acute effects of inorganic nitrate as compared with<br /><br>a placebo on brain vascular function, as assessed by CBF. Additionally, the<br /><br>effect of brain insulin-sensitivity changes on cognitive performance in the<br /><br>domain of executive function and spatial memory will be investigated using<br /><br>CANTAB, after consumption of nitrate as compared with placebo</p><br>