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

NCT03335930 | Completed DMC

• 1 other identifier: TSGHIRB: 097-05-157
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

exercise; blood glucose response; metabolic control; type 2 diabetes.

Outcome Measures

Primary Outcomes (1)

• exercise-induced glucose response

  trend analysis of exercise-induced glucose response following a 12-week exercise training

  12 weeks

Secondary Outcomes (2)

• metabolic control/ trend of before-exercise blood glucose

  12 weeks

• trend of post-exercise blood glucose

  12 weeks

Study Arms (3)

Morning exercise

EXPERIMENTAL

To exercise at morning (08:00-10:00)

Behavioral: a 12-week moderate-intensity exercise training

Afternoon exercise

ACTIVE COMPARATOR

To exercise at afternoon (14:00-16:00)

Behavioral: a 12-week moderate-intensity exercise training

Evening exercise

ACTIVE COMPARATOR

To exercise at evening (18:00-20:00)

Behavioral: a 12-week moderate-intensity exercise training

Interventions

a 12-week moderate-intensity exercise training BEHAVIORAL

a 12-week, aerobic, moderate-intensity exercise training

Also known as: aerobic exercise training

Afternoon exercise; Evening exercise; Morning exercise

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Related Publications (7)

• Duclos M, Virally ML, Dejager S. Exercise in the management of type 2 diabetes mellitus: what are the benefits and how does it work? Phys Sportsmed. 2011 May;39(2):98-106. doi: 10.3810/psm.2011.05.1899.

  PMID: 21673489 RESULT

• Karjalainen JJ, Kiviniemi AM, Hautala AJ, Piira OP, Lepojarvi ES, Perkiomaki JS, Junttila MJ, Huikuri HV, Tulppo MP. Effects of physical activity and exercise training on cardiovascular risk in coronary artery disease patients with and without type 2 diabetes. Diabetes Care. 2015 Apr;38(4):706-15. doi: 10.2337/dc14-2216. Epub 2015 Jan 15.

  PMID: 25592198 RESULT

• Koivula RW, Tornberg AB, Franks PW. Exercise and diabetes-related cardiovascular disease: systematic review of published evidence from observational studies and clinical trials. Curr Diab Rep. 2013 Jun;13(3):372-80. doi: 10.1007/s11892-013-0373-0.

  PMID: 23494754 RESULT

• Rohling M, Herder C, Roden M, Stemper T, Mussig K. Effects of Long-Term Exercise Interventions on Glycaemic Control in Type 1 and Type 2 Diabetes: a Systematic Review. Exp Clin Endocrinol Diabetes. 2016 Sep;124(8):487-494. doi: 10.1055/s-0042-106293. Epub 2016 Jul 20.

  PMID: 27437921 RESULT

• Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.

  PMID: 21115771 RESULT

• Gulve EA. Exercise and glycemic control in diabetes: benefits, challenges, and adjustments to pharmacotherapy. Phys Ther. 2008 Nov;88(11):1297-321. doi: 10.2522/ptj.20080114. Epub 2008 Sep 18.

  PMID: 18801852 RESULT

• Way KL, Hackett DA, Baker MK, Johnson NA. The Effect of Regular Exercise on Insulin Sensitivity in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Diabetes Metab J. 2016 Aug;40(4):253-71. doi: 10.4093/dmj.2016.40.4.253. Epub 2016 Aug 2.

  PMID: 27535644 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Chia-Huei Lin, PhD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 8, 2017
• Study Start: March 1, 2009
• Primary Completion: November 30, 2009
• Study Completion: December 31, 2009
• Last Updated: November 9, 2017

Record last verified: 2017-11