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

November 7, 2017 updated by: CHIA-HUEI LIN, PhD, Tri-Service General Hospital

Tri-Service General Hospital, National Defense Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective and longitudinal design using purposive sampling was used. All eligible Taiwanese participants with T2DM at a medical centre were invited to participate in the exercise-training programme that included three sessions per week, 30 minutes per session for 12 weeks (total 36 sessions). Each participant's exercise sessions were equally randomised into three times of day (morning/08:00-10:00, afternoon/14:00-16:00 evening/18:00-20:00) using permuted-block randomisation. Capillary blood glucose samples were obtained before and after each 30-minute moderate-intensity (60% VO2max) exercise session. The EIGR, described as the difference between BEBG and PEBG values, was calculated.

Participants and setting: Participants with T2DM being seen at an outpatient clinic in a northern Taiwan medical centre were recruited by an endocrinology/metabolism physician. Participants, 40-60 years of age, diagnosed as having T2DM based on the criterion of the American Diabetes Association, and were being treated with oral antidiabetic medications only were eligible. Other inclusion criteria were (1) able to speak and understand Mandarin; (2) able to walk without assistance; (3) have no regular exercise habit; and (4) agree to join in a 12-week moderate-intensity exercise training after passing a graded exercise test (GXT), described below. Exclusion criteria included insulin therapy, a history of cancer, end-stage renal disease with dialysis, an 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.

Under an effect size of 0.2, thirty-six numbers of measurements with a correlation efficient of 0.32 among repeated measures, an expected power of 0.7 to 0.8, and an alpha of 0.05, the required sample size was between 12 and 14 based on repeat measures (within factors). Therefore, initially 52 T2DM patients were approached and seventeen eligible participants were invited by a research nurse to receive GXT. Fifteen passed the exercise test based on the guidelines of the American College of Sports Medicine (ACSM) for exercise testing. A second research nurse assessed the baseline characteristics (eg, self-reported demographics and lifestyle patterns, blood analyses and anthropometric measures) of the final 15 participants. Participants were then invited to perform 36 exercise sessions (3 sessions/week for 12 weeks), which were randomly assigned to morning, afternoon, or evening using permuted-block randomization, except two dropped out after exercise test.

Graded exercise test: The GXT was performed using a motorised treadmill (Trackmaster 400, JAS Fitness System, USA) for identification of maximum oxygen uptake (VO2max), maximum heart rate (HRmax) and the risk for potentially life-threatening cardiovascular disease (eg, myocardial infarction). GXT procedures followed a modified Balke protocol.20 Two observers (a medical/rehabilitation doctor and a research nurse) were involved with each patient throughout the GXT. The GXT was immediately stopped if the patient complained of exhaustion; reached maximum heart rate or VO2max, determined by the maximal amount of blood the heart pumps per minute (cardiac output) and the amount of oxygen utilised by the exercising muscles (arterial-venous oxygen difference); had a respiratory exchange ratio >1.15; developed symptoms such as chest pain, dyspnea, pallor, diaphoresis or dizziness; had systolic pressure greater than 250 mm Hg or diastolic pressure greater than 120 mm Hg; had a decrease in systolic pressure of more than 10 mm Hg compared to the systolic pressure at rest; or requested stopping the test.

Ethical consideration: Institutional review board approval (TSGHIRB: 097-05-157) was obtained from Tri-Service General Hospital in Taiwan. All participants gave written informed consent when invited to join the study. Participants were assured that their participation was entirely voluntary and that they could withdraw at any time.

Data analysis: Statistical analyses were performed by SPSS version 16.0 (SPSS Inc., Chicago, IL). Descriptive data are presented as mean/standard deviation (SD) and numbers/percentage (%). Before evaluating the trend of blood glucose response during the 12-week/36-session exercise-training programme, two variables including "training month (1st, 2nd and 3rd month of the training)" and "timing of exercise sessions (1st to 36th session of exercise)" were coded. With generalised estimating equations (GEE), the investigators examined the change patterns of BEBG, PEBG and EIGR over time during the training programme. The trend analyes of BEBG, PEBG and EIGR were adjusted for covariates (i.e, age, gender, baseline body mass index, VO2max, HgbA1c, antidiabetic medication (metformin, sulfonylureas or repaglinide) and exercise time of day (morning, afternoon or evening). When evaluating the predictors of EIGR and PEBG, univariable analysis was applied first and, following the multivariable analysis, incorporated with those significant covariates from univariable analysis. All of the statistical analyses were two-tailed and considered significant at p < .05.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • aerobic exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise-induced glucose response
Time Frame: 12 weeks
trend analysis of exercise-induced glucose response following a 12-week exercise training
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
trend of post-exercise blood glucose
Time Frame: 12 weeks
trend analysis of post-exercise blood glucose following a 12-week exercise training
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Chia-Huei Lin, PhD, Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

November 30, 2009

Study Completion (Actual)

December 31, 2009

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

November 5, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGHIRB: 097-05-157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After our research results were published. We will share our Study Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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