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Trial record 45 of 101 for:    Recruiting, Not yet recruiting, Available Studies | "Blood Glucose"

Circadian High Intensity Interval Training Study

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ClinicalTrials.gov Identifier: NCT03553524
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Harriet Wallberg, Karolinska Institutet

Brief Summary:
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Independent Other: morning HIIT --> afternoon HIIT Other: afternoon HIIT --> morning HIIT Not Applicable

Detailed Description:

High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. Additionally, we aim to to elucidate the underlying hormonal changes and fuel utilization preference responsible for the differing blood glucose response.

A randomized cross-over trial with 40 participants with type 2 diabetes will be performed. The participants will be examined on three occasions on an in-patient basis (36-hour hospital visits). On visit 1 baseline (no exercise) measurements will be established. On visit 2 the participants will perform a single bout of HIIT either in the morning (08:30) or afternoon (19:30). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Fuel utilization preference will be measured by respiratory exchange ratio (RER)during exercise.

The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose values, based on the preliminary data gathered from the 'free living' pilot study. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the specific factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated.

Preliminary data from the pilot study

A randomised cross-over pilot study with 11 participants with type 2 diabetes in 'free living' conditions has been performed. Glycaemia measurements were collected by continuous glucose monitors (CGMs) for 2 weeks pre-training and for the duration of the study. The participants were assigned to either morning (08:00) or afternoon (16:00) training regime consisting of 6 HIIT occasions over 2 weeks. Following a 2-week 'wash-out' period, the participants performed the opposing exercise training regime. The preliminary results show that HIIT is more efficacious in improving glycaemia when performed in the afternoon, rather than in the morning.

This pilot was a field-based study in 'free-living' individuals, thus the specific factors responsible for the differing blood glucose levels between morning and afternoon exercise trials remain to be elucidated. Now is the aim to perform a study in controlled condition, limiting the effects food intake, medication and sleep-wake cycle disruption and measuring the effects of a single HIIT bout on glycaemia. The hypothesis is that HIIT bout at different times of day diversely affects diurnal hormonal rhythms, accounting for the differing glycaemic responses.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Time of Day Dependant Effects of High Intensity Interval Training on Blood Glucose Levels in Participants With Type 2 Diabetes
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Morning first

Both arms of the study will perform the baseline measurements during visit 1. Arm 1 of the study will perform HIIT at 08:30 during visit 2, and after a 1-week washout period will perform HIIT at 19:30 during visit 3.

HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown.

Other: morning HIIT --> afternoon HIIT
Arm 1 will start with morning HIIT at visit 2 and afternoon HIIT at visit 3

Experimental: Afternoon first

Both arms of the study will perform the baseline measurements during visit 1. Arm 2 of the study will perform HIIT at 19:30 during visit 2, and after a 1-week washout period will perform HIIT at 08:30 during visit 3.

HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown.

Other: afternoon HIIT --> morning HIIT
Arm 2 will start with afternoon HIIT at visit 2 and morning HIIT at visit 3




Primary Outcome Measures :
  1. Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. [ Time Frame: 36 hours on: visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT) ]
    Continuous glucose monitor-based blood glucose measurements will be recorded and blood samples will be obtained before and after exercise. Additional repeated blood samples will be collected every 4-6 hours during the stay.


Secondary Outcome Measures :
  1. Blood insulin levels (mIU/l) will be determined in collected blood samples and compared between exercise interventions (morning vs afternoon HIIT) as well as to no-exercise baseline measurements (morning / afternoon HIIT vs baseline). [ Time Frame: Every 4-6 hours during 36 hours on visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT) ]
  2. Respiratory exchange ratio (RER) [ Time Frame: During exercise on visit 2 (Arm 1 - Morning HIIT (08:30) / Arm 2 - Afternoon HIIT (19:30)) and visit 3 (Arm 1 - Afternoon HIIT (19:30) / Arm 2 - Morning HIIT (08:30)) ]
    Respiratory exchange ratio (RER) will be determined for the duration of the exercise bout utilizing a face-mask gas collector coupled to indirect calorimeter. RER comparisons will be made between the two exercise interventions (morning vs afternoon HIIT).



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Ages Eligible for Study:   45 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Age: 45 - 68 years
  • Body Mass Index (BMI): 23 - 33 kg/m2
  • Participant diagnosed with Type 2 Diabetes (insulin independent)
  • Ability to provide informed consent
  • Ability to complete the exercise regiment

Exclusion criteria:

  • Medications: Insulin
  • Current nicotine user (cigarettes, snus, nicotine gum)
  • Past nicotine use less than 6 months before inclusion in the study
  • Pre-existing cardiovascular condition: Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension
  • Pre-existing blood-borne disease: HIV, Hepatitis C, MRSA
  • Pre-existing systemic or localized rheumatic illness
  • Cancer
  • Pre-existing psychiatric disorder
  • Another pre-existing systemic disease

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): NCT03553524


Contacts
Contact: Harriet Wallberg-Henriksson, MD, PhD +46706296470 harriet.wallberg@ki.se

Sponsors and Collaborators
Karolinska Institutet

Responsible Party: Harriet Wallberg, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03553524     History of Changes
Other Study ID Numbers: CircHIIT Study
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Harriet Wallberg, Karolinska Institutet:
Type 2 Diabetes
Insulin independent
HIIT
CGM-based blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases