Effect of Continuous vs Intermittent Aerobic Exercise on Glycemic Control in a Barbadian Population With Type 2 Diabetes

NCT04006938 | Unknown

• 1 other identifier: KCK00000001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study will be to evaluate and compare the effect of a single 30-minute bout of moderate intensity aerobic exercise to the effect of three 10-minute pre-prandial bouts of energy-matched and volume-matched aerobic exercise on 2-hr post prandial and fasting blood sugar levels, in a sample of type 2 diabetes patients, aged 30-65 years, living in Barbados Research Hypotheses: The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower post prandial blood sugar levels when compared to the single bout of moderate intensity aerobic exercise. The three bouts of pre-prandial moderate intensity aerobic exercise will result in lower fasting blood sugar levels on the morning following the exercise intervention when compared to the single bout of moderate intensity aerobic exercise

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• 2 hour post prandial blood glucose level after breakfast

  blood glucose level 2 hours after breakfast consumption

  single point measurement taken 2 hours after breakfast consumption

• 2 hour post prandial blood glucose level after lunch

  blood glucose level 2 hours after lunch consumption

  single point measurement taken 2 hours after lunch consumption

• 2 hour post prandial blood glucose level after dinner

  blood glucose level 2 hours after dinner consumption

  single point measurement taken 2 hours after dinner consumption

• Fasting blood sugar level

  blood sugar level after 8 hours of fasting performed on day following exercise intervention

  single point measurement taken after 8 hours of fasting

Study Arms (2)

Single Bout ('S') - 30 minutes of moderate intensity cycling

EXPERIMENTAL

Subjects will perform a single 30-minute bout of moderate intensity cycling before breakfast

Behavioral: Single Bout ('S')

Multiple Bout ('M')

EXPERIMENTAL

Subjects will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

Behavioral: Multiple Bout ('M')

Interventions

Single Bout ('S') BEHAVIORAL

Each subject will perform a single bout of 30-minutes of moderate-intensity cycling before breakfast

Single Bout ('S') - 30 minutes of moderate intensity cycling

Multiple Bout ('M') BEHAVIORAL

Each subject will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner

Multiple Bout ('M')

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30-65 years
• Documented diagnosis of type 2 diabetes (HbA1C ≥ 6.5%)

You may not qualify if:

• Subjects currently managed on prandial insulin
• Subjects who have recently started insulin (within the previous month)
• Subjects with a history of frequent hypoglycemic episodes within the previous 2 weeks,
• Pregnancy
• Subjects with a history of cerebrovascular accident, myocardial infarction, chronic kidney disease, autonomic and peripheral neuropathy
• Subjects with contraindications to exercise according to ACSM 2018 guidelines

Sponsors & Collaborators

• Springfield College: lead

Related Publications (3)

• Francois ME, Baldi JC, Manning PJ, Lucas SJ, Hawley JA, Williams MJ, Cotter JD. 'Exercise snacks' before meals: a novel strategy to improve glycaemic control in individuals with insulin resistance. Diabetologia. 2014 Jul;57(7):1437-45. doi: 10.1007/s00125-014-3244-6. Epub 2014 May 10.

  PMID: 24817675 BACKGROUND

• van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ. Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care. 2013 Nov;36(11):3448-53. doi: 10.2337/dc12-2620. Epub 2013 Sep 16.

  PMID: 24041682 BACKGROUND

• American College of Sports Medicine. (2018). ACSM's guidelines for exercise testing and prescription (5th edn.). Philadelphia, PA: Lippincott Williams & Wilkins.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Samuel Headley, PhD

  Springfield College

  STUDY CHAIR

Central Study Contacts

Kristyn C Kirton, MBBS

CONTACT

4133426892; kkirton@springfieldcollege.edu

Samuel Headley, PhD

CONTACT

413-748-3340; sheadley@springfieldcollege.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The proposed study is a crossover randomized controlled study. There will be two intervention groups - a single 30-minute bout of moderate intensity aerobic exercise before breakfast and three (3) 10-minute bouts of moderate intensity aerobic activity before breakfast, lunch and dinner.

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07