Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

Microvascular Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145027
• Other study ID #: do200812
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: October 20, 2010
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2010
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Microvascular Function

Intervention

Other:
• Breakfast tray
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.

Locations

Country	Name	City	State
Brazil	Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional capillary density (number of perfused capillaries on the studied skin area)		up to 30 minutes	No
Secondary	cephalic phase of insulin secretion (the occurence of increase in markers of this phase, such as insulin, C-peptide and pancreatic polypeptide)		Up to 30 minutes	No