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Exercise-induced Blood Glucose Response in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335930
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
CHIA-HUEI LIN, PhD, Tri-Service General Hospital

Brief Summary:
Exercise is recommended for type 2 diabetes, which is a global health problem. However, during a moderate-intensity exercise training there is an unpredictable risk of hypoglycemia for patients with type 2 diabetes. Therefore, the investigators aim to explore trends in blood glucose levels in response to a 12-week moderate-intensity exercise training in patients with type 2 diabetes and to explore the predictors of post-exercise blood glucose (PEBG) and exercise-induced glucose response (EIGR). A descriptive and longitudinal design was conducted. Eligible type 2 diabetes patients were recruited from outpatient clinics of a medical center in Taiwan and invited to participate in a 12-week moderate-intensity exercise-training program. Each participant received 36 repeated measures of blood glucose during the exercise training program. Participants were randomly assigned to one of three exercise times (morning/afternoon/evening). Each exercise session was took place 1 to 2 hours after a meal. Capillary blood glucose levels were measured pre- and post-exercise. The EIGR was calculated from subtracting the PEBG from the before-exercise blood glucose (BEBG). Generalized estimating equation was used to examine the trends and predictors of PEBG and EIGR.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: a 12-week moderate-intensity exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
  1. Participants were randomly assigned to one of three exercise times (morning/08:00-10:00, afternoon/14:00-16:00 evening/18:00-20:00).
  2. Training protocol: Treadmills were used for the aerobic exercise training. Participants received supervised exercise training three times per week on alternate days for 12 weeks at the medical centre.
  3. All participants followed this training protocol and maintained their usual lifestyles. The duration of each training session was 30 minutes and took place 1 to 2 hours after a meal.
  4. The intensity of the training was set at 60% VO2max (approximately equal to 72% HRmax) obtained from the GXT.
  5. During each session of the 30-minute aerobic exercise training, the patient's heart rate was maintained at 72% of heart rate maximal on treadmill. Appropriate speed and grade were used to achieve the target heart rate being tracked by the heart rate monitor and to accurately control the required exercise intensity.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tri-Service General Hospital, National Defense Medical Center
Actual Study Start Date : March 1, 2009
Actual Primary Completion Date : November 30, 2009
Actual Study Completion Date : December 31, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morning exercise
To exercise at morning (08:00-10:00)
Behavioral: a 12-week moderate-intensity exercise training
a 12-week, aerobic, moderate-intensity exercise training
Other Name: aerobic exercise training

Active Comparator: Afternoon exercise
To exercise at afternoon (14:00-16:00)
Behavioral: a 12-week moderate-intensity exercise training
a 12-week, aerobic, moderate-intensity exercise training
Other Name: aerobic exercise training

Active Comparator: Evening exercise
To exercise at evening (18:00-20:00)
Behavioral: a 12-week moderate-intensity exercise training
a 12-week, aerobic, moderate-intensity exercise training
Other Name: aerobic exercise training




Primary Outcome Measures :
  1. exercise-induced glucose response [ Time Frame: 12 weeks ]
    trend analysis of exercise-induced glucose response following a 12-week exercise training


Secondary Outcome Measures :
  1. metabolic control/ trend of before-exercise blood glucose [ Time Frame: 12 weeks ]
    trend analysis of before-exercise blood glucose following a 12-week exercise training

  2. trend of post-exercise blood glucose [ Time Frame: 12 weeks ]
    trend analysis of post-exercise blood glucose following a 12-week exercise training



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40-60 years of age
  • diagnosed as having T2DM based on the criterion of the American Diabetes Association
  • being treated with oral antidiabetic medications
  • able to speak and understand Mandarin
  • able to walk without assistance
  • have no regular exercise habit
  • agree to join in a 12-week moderate-intensity exercise training after passing a graded exercise test.

Exclusion Criteria:

  • receiving insulin therapy
  • a history of cancer, end-stage renal disease with dialysis
  • inability to participate in exercise training due to comorbid neurological and musculoskeletal conditions
  • severe comorbidity or complications such as heart failure, autonomic neuropathy, and recent stroke within 6 months.

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): NCT03335930


Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Chia-Huei Lin, PhD Tri-Service General Hospital
Publications of Results:

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Responsible Party: CHIA-HUEI LIN, PhD, Assistant Professor, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03335930    
Other Study ID Numbers: TSGHIRB: 097-05-157
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After our research results were published. We will share our Study Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR).

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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 CHIA-HUEI LIN, PhD, Tri-Service General Hospital:
exercise
blood glucose response
metabolic control
type 2 diabetes.
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases