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Trial record 9 of 1046 for:    Area Under Curve AND insulin

Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function

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ClinicalTrials.gov Identifier: NCT03374436
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Mitacs
CoreHealth Technologies Inc.
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Tracking Information
First Submitted Date  ICMJE December 11, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date November 28, 2018
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
Plasma insulin area under the curve [ Time Frame: Measured across 9 hours of each intervention day ]
The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03374436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • Saliva insulin area under the curve [ Time Frame: Measured across 9 hours of each intervention day ]
    The saliva insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
  • Plasma glucose area under the curve [ Time Frame: Measured across 9 hours of each intervention day ]
    The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
  • Plasma triglyceride area under the curve [ Time Frame: Measured across 9 hours of each intervention day ]
    The plasma triglyceride concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
  • Plasma non-esterified fatty acids area under the curve [ Time Frame: Measured across 9 hours of each intervention day ]
    The plasma non-esterified fatty acid concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
  • Femoral artery flow-mediated dilation [ Time Frame: Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day ]
    Flow-mediated dilation of femoral artery measured by vascular ultrasound
  • Cerebrovascular function [ Time Frame: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day ]
    Cerebrovascular function measured by transcranial doppler ultrasound
  • Cognitive function [ Time Frame: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day ]
    Cognitive function measured by Computerized Neurocognitive Assessment Software (CNS) Vital Signs test battery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function
Official Title  ICMJE Salivary Insulin Profiles Throughout the Day in Healthy Humans
Brief Summary Prolonged sitting has been shown to impair metabolism and vascular function. The overall purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with brief (~20 second) stair climbing exercise "snacks" can improve markers of metabolic control and vascular health in healthy young male participants and in males or females with overweight/obesity who are at risk of insulin resistance. An additional purpose is to determine if saliva insulin can be used as a valid indicator of blood insulin when measured throughout the day in sedentary and active conditions and when diets with different amounts of carbohydrates are consumed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants complete three conditions in a repeated crossover design.
Masking: None (Open Label)
Masking Description:
It is not possible to mask the exercise or diet interventions.
Primary Purpose: Other
Condition  ICMJE
  • Physical Activity
  • Diet Modification
Intervention  ICMJE
  • Behavioral: High-Carbohydrate Sedentary
    Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.
  • Behavioral: High-Carbohydrate Active
    Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint "snack") for a total of 8 active breaks.
  • Behavioral: Low-carbohydrate Sedentary
    Three low-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period. This condition will provide a condition where the blood glucose and insulin responses are relatively low and stable throughout the day.
Study Arms  ICMJE
  • Experimental: High-Carbohydrate Sedentary
    Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals)
    Intervention: Behavioral: High-Carbohydrate Sedentary
  • Experimental: High-Carbohydrate Active
    Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals) but will complete 8 stair climbing sprint "snacks" once per hour involving ascending 3 flights of stairs at a vigorous pace (~20 seconds each).
    Intervention: Behavioral: High-Carbohydrate Active
  • Active Comparator: Low-Carbohydrate Sedentary
    Participants will remain seated for 9 hours (except for using the restroom) while consuming a low-carbohydrate diet (3 meals)
    Intervention: Behavioral: Low-carbohydrate Sedentary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Lean Group Inclusion Criteria:

Non-smoking

Lean Group Exclusion Criteria:

Diagnosed with diabetes or prediabetes (fasting blood sugar more than 6.0 mmol/l) or any other chronic condition that may impact glucose or insulin levels.

BMI is over 25 kg/m2 Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.

Overweight/Obese Group Inclusion Criteria:

Elevated waist circumference (>102 cm for male and >88 cm for female)

Overweight/Obese Group Exclusion Criteria:

Diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374436
Other Study ID Numbers  ICMJE H17-01747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We will share individual patient data (de-identified) with researchers upon request.
Responsible Party Jonathan Little, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE
  • Mitacs
  • CoreHealth Technologies Inc.
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP