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High-intensity Interval Training for Obese Individuals

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ClinicalTrials.gov Identifier: NCT04075799
Recruitment Status : Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Collaborator:
New Mexico Inbre
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:

This proposal's objective is to investigate the effects of a high-intensity intermittent stair climbing program on insulin resistance in individuals with obesity and at risk of type 2 diabetes (T2D).

Obesity (defined as body mass index ≥ 30kg/m2) is a major risk factor for T2D. The connection between obesity and T2D involves the development of insulin resistance (IR). Exercise training is an effective non-pharmacological approach to prevent and treat IR. Despite the efficacy of exercise training on ameliorating IR, most individuals do not achieve the minimum recommended levels of physical activity and cite "lack of time" and difficulty in accessing exercise facilities as barriers to exercise. Proposed as a time-efficient alternative, high-intensity interval training (HIIT), which consists of short periods of high-intensity efforts alternated with brief periods of recovery, is an efficient strategy to improve IR. However, most HIIT protocols have been studied in laboratory-based settings requiring access to specialized equipment (i.e. treadmills, cycle ergometers) and are not practical for the general population. The use of high-intensity intermittent stair climbing may be a suitable exercise strategy from an accessibility perspective. With evidence to suggest improvements in IR following HIIT in individuals with obesity or T2D, the application of a similar approach using high-intensity intermittent stair climbing to directly assess changes in IR in a population at risk of T2D populations is warranted. Completion of this study will help elucidate if an easy to implement, time-efficient and low-cost exercise training program improves insulin resistance in individuals at risk of T2D.


Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Other: high-intensity interval training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A HIIT to Improve Metabolic Health in Obese Adults With Insulin Resistance
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: training
8 weeks using stair climbing with a frequency of thrice a week. For the first week of the stair training exercise program subjects will meet at UNM's Teaching Education Building (Stair Case 2). The following 7 weeks subjects can perform the exercise program at a staircase most convenient to them and approved by the research team. The warm-up will consist of 2 minutes of ascending and descending the stairs at a comfortable pace. The high-intensity intermittent exercise will be comprised of 6-12 x 30-seconds bout of ascending at an all-effort. A 30- seconds walking recovery will occur between the exercise bouts. After the exercise session the subject will walk during a 2-minute cool down. Every session will last between 10 to 15 minutes. The number of bouts (6-12) will be increased progressively over the weeks.
Other: high-intensity interval training
The HIIT protocol consists of 8 weeks using stair climbing three times per week. The warm-up will consist of 2 minutes of ascending and descending the stairs at a comfortable pace. The high-intensity intermittent exercise will comprise 6-12 x 30-seconds bouts of ascending at an all-effort. A 30- seconds walking recovery will occur between the exercise bouts. Post-exercise the subject will walk during a 2-minute cool down. Every session will last between 10 to 15 minutes. The number of bouts (6-12) will be increased progressively over the weeks. The first (week 1) and final week (week 8) of the exercise program will be monitored by a trained exercise physiologist. During supervised visits, heart rate and rating of perceived exertion (OMNI scale) will be measured at the end of each bout and after active recovery. Subjects will have the option to request further monitoring if desired.




Primary Outcome Measures :
  1. Change in HOMA-IR concentration [ Time Frame: Before the 8-week intervention and 72-hours after last exercise session. ]
    homeostasis model assessment for insulin resistance (HOMA-IR)


Secondary Outcome Measures :
  1. Change in Body Composition [ Time Frame: After a 10-hour fast and at least 72 hours before and after the training ]
    underwater weighing (UWW)

  2. Change in Maximal Oxygen Consumption [ Time Frame: After a 10-hour fast and at least 72 hours before and after the training ]
    maximal ramp graded test protocol on a treadmill



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-45 years,
  • body mass index (BMI) equal or superior than 30 kg/m²;
  • homeostasis model assessment for insulin resistance (HOMA-IR) ≥ 2.71,
  • no fear of being totally submerged underwater for 2 to 10 seconds
  • comfortable having blood taken from a forearm vein.

Exclusion Criteria:

  • smokers,
  • currently taking any medications known to impact their metabolism or immune system,
  • bleeding or blood clotting disorder,
  • physical injury,
  • physical limitations,
  • diagnostic of T2D,
  • currently under the active care of a physician for any condition that may interfere with their safety.
  • cardiovascular conditions (cardiac, peripheral vascular, or cerebrovascular disease),
  • diseases that prevent participation in a maximal effort test without physician clearance per the American College of Sports Medicine (ACSM) guidelines (2017).
  • signs and symptoms of cardiovascular disease, at rest or during physical activity, which includes pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075799


Contacts
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Contact: Fabiano Amorim, PhD (505)277-3795 amorim@unm.edu

Sponsors and Collaborators
University of New Mexico
New Mexico Inbre
Investigators
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Principal Investigator: Fabiano Amorim, PhD University of New Mexico
Publications of Results:
Other Publications:
WHO WHO. Obesity and overweight 2017

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT04075799    
Other Study ID Numbers: 07419
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of New Mexico:
obesity
insulin resistance
high-intensity interval training
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases