Skip to main content
OpenTrials
Completed

NCT Number: NCT01145027

Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute interval between them, after an 10-h overnight fast in a temperature controlled room. The subjects will be randomized in two groups: one will receive a sensorial stimulus during the interval (stimulus group - SG) and the other will receive no stimulus (control group - CG). The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.

Baseline microvascular parameters will be compared to the results after the interval. The investigators hypothesize that the SG will have greater capillary recruitment due to a possible effect of physiologically secreted insulin provoked by the sensorial stimulation (cephalic phase of insulin secretion).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Microvascular Function

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Rio de Janeiro, 20550-013, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers
  • Aged between 18 and 30 years
  • BMI between 18.5 and 24.9 kg/m2

Exclusion criteria

  • Diabetes mellitus, glucose intolerance or altered fasting glucose;
  • Hypertension (Systolic pressure ≥ 130 mmHg and diastolic pressure ≥ 80 mmHg);
  • HOMA-index ≥ 2.71
  • Dyslipidemia
  • Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
  • Smoking
  • Chronic use of any medication

Treatment and study plan

Breakfast tray

Other

The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.

Primary outcomes

  1. functional capillary density (number of perfused capillaries on the studied skin area)

    Time frame: up to 30 minutes

Secondary outcomes

  1. cephalic phase of insulin secretion (the occurence of increase in markers of this phase, such as insulin, C-peptide and pancreatic polypeptide)

    Time frame: Up to 30 minutes

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Relations Among Cephalic Phase of Insulin Secretion, Body Composition, Dietary Intake and Microvascular Reactivity in Healthy Young Men

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Oct 21, 2010

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.