Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01145027
First received: June 14, 2010
Last updated: October 20, 2010
Last verified: June 2010
  Purpose

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).


Condition Intervention
Microvascular Function
Other: Breakfast tray

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Relations Among Cephalic Phase of Insulin Secretion, Body Composition, Dietary Intake and Microvascular Reactivity in Healthy Young Men

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • functional capillary density (number of perfused capillaries on the studied skin area) [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Experimental: Sensorial Stimulus
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145027

Locations
Brazil
Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular
Rio de Janeiro, Brazil, 20550-013
Sponsors and Collaborators
Rio de Janeiro State University
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Caroline Buss, Master Rio de Janeiro State University
  More Information

No publications provided by Rio de Janeiro State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caroline Buss, RD, MSc, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01145027     History of Changes
Other Study ID Numbers: do200812
Study First Received: June 14, 2010
Last Updated: October 20, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Rio de Janeiro State University:
Capillary recruitment
Cephalic Phase of Insulin Secretion
Dietary Intake

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014