Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

NCT01145027 | Completed

• 1 other identifier: do200812
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Microvascular Function

Keywords

Capillary recruitment; Cephalic Phase of Insulin Secretion; Dietary Intake

Outcome Measures

Primary Outcomes (1)

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

  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)

  Up to 30 minutes

Study Arms (2)

Control group

NO INTERVENTION

Sensorial Stimulus

EXPERIMENTAL

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, in order to trigger the cephalic phase of insulin secretion

Other: Breakfast tray

Interventions

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.

Sensorial Stimulus

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Rio de Janeiro, Rio de Janeiro, 20550-013, Brazil

Location

Related Publications (1)

• Buss C, Kraemer-Aguiar LG, Maranhao PA, Marinho C, de Souza Md, Wiernsperger N, Bouskela E. Novel findings in the cephalic phase of digestion: a role for microcirculation? Physiol Behav. 2012 Feb 28;105(4):1082-7. doi: 10.1016/j.physbeh.2011.12.004. Epub 2011 Dec 14.

  PMID: 22197630 DERIVED

Study Officials

• Caroline Buss, Master

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2010-06

Locations

BR (1)