Training, Detraining, Retraining and Glycemic Control in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Savvas P. Tokmakidis, Ph.D., Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT01580475
First received: March 18, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose
  • This study examine the effects of training, detraining and retraining, using a combined strength and aerobic exercise program, on physiological parameters in patients with type 2 diabetes.
  • Thirteen women with type 2 diabetes followed a supervised aerobic and strength training program for 9 months, interrupted for 3 months (detraining) and resumed again for a period of 9 months (retraining).
  • Training improved body mass index, fasting plasma glucose,postprandial glucose, glycosylated hemoglobin, peak oxygen consumption,power output and total muscle strength. Detraining reversed PPG, HbA1C and physical fitness parameters. Resumption of training however, improved further the initial training adaptations.
  • Diabetic patients should follow a regular and uninterrupted exercise program throughout life in order to control glucose metabolism and improve health status.

Condition Intervention
Type 2 Diabetes
Other: Training - detraining - retraining

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Training, Detraining and Retraining Effects on Glycemic Control and Physical Fitness in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Democritus University of Thrace:

Primary Outcome Measures:
  • Changes from baseline in glycemic control measurements (follow-up for 21 months) at training (9 months), detraining (3 months) and retraining (9 months) [ Time Frame: Changes from baseline in HbA1C, FPG and PPG at training (9 months), detraining (11 months) and retraining (21 months) ] [ Designated as safety issue: No ]
    Glycemic control was evaluated by the measurement of fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (HbA1C). PPG was calculated by the mean of four values measured at the first week of every period (baseline, 9th, 12th and 21st months).


Secondary Outcome Measures:
  • Evaluation of body composition [ Time Frame: Changes from baseline in body composition assessment at training (9 months), detraining (3 months), retraining (9 months) ] [ Designated as safety issue: No ]
    Anthropometric Assessment: Body weight, height, BMI and waist circumference (WC).

  • Peak oxygen consumption (VO2peak) [ Time Frame: Changes from baseline in VO2peak at training (9 months), detraining (11 months) and retraining (21 months) ] [ Designated as safety issue: No ]
    Measurement of Peak Oxygen Uptake: Patients underwent a symptom-limited graded exercise test on a cycle-ergometer (60 rpm). The initial load was set at 25W and increased gradually by 25W every 2-min until the patients were unable to continue. VO2peak was determined by open-circuit spirometry (E. Jaeger, IEC 601-1, Germany).

  • Measurement of muscular strength in patients with type 2 diabetes [ Time Frame: Changes from baseline in muscular strength at training (9 months), detraining (11 months) and retraining (21 months) ] [ Designated as safety issue: No ]
    Muscle Strength: Maximum strength was measured with the one-repetition maximum (1 RM) method and total muscle strength was calculated as the sum of leg extension and bench press.


Enrollment: 13
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle (exercise training)
Training, detraining and retraining
Other: Training - detraining - retraining
Thirteen women with type 2 diabetes followed a supervised aerobic and strength training program for 9 months, interrupted for 3 months (detraining) and resumed again for a period of 9 months (retraining).

Detailed Description:

During the last decades, the positive effects of aerobic exercise in patients with type 2 diabetes have been well documented. Recently, resistance exercise has gained popularity in diabetic patients since several studies have indicated that this type of training is safe and induces favorable adaptations in physical fitness and metabolic profile. According to recent scientific evidence, a complete rehabilitation program for patients with type 2 diabetes should combine both strength and aerobic exercise; thus the American Diabetic Association in their latest guidelines recommends strength training as part of an exercise program at least two times a week.

On the contrary to the well documented effects of physical training, there is lack of data on the negative alterations of detraining in patients with type 2 diabetes. The partial or complete loss of training-induced adaptations as a consequence of training reduction or cessation is well-documented by several detraining studies in healthy subjects, older individuals and patients with coronary artery disease.

For example, the investigators know that even 6 days of physical inactivity reduces insulin action in well-trained runners which is attributed to the significant reduction in the muscle GLUT-4 level. Factors such as illness, injury, travel or vacation may interrupt the training process for longer periods, affecting the treatment in people with type 2 diabetes. For this population, it is important to quantify changes in physiological and metabolic parameters resulting from the cessation of exercise, since exercise training is a major therapeutic method.

To the best of our knowledge, there is no data concerning the loss of physiological adaptations which occurs after exercise cessation in patients with type 2 diabetes, which have previously trained for a long period of time. The current study evaluated the effects of three months of detraining after nine months of a combined strength and aerobic training program on glycemic control, body composition, peak oxygen consumption (VO2peak) and muscular strength in patients with type 2 diabetes. Further, the investigators examined the extent of the regained adaptations after the resumption of training for a period of nine months.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • without micro- and macroangiopathy

Exclusion Criteria:

  • type 1 diabetes
  • cardiovascular disease,
  • confirmed retinopathy/nephropathy/neuropathy,
  • uncontrolled diabetes mellitus (HbA1c>10%).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580475

Locations
Greece
Savvas P. Tokmakidis
Komotini, Greece, 691 00
Sponsors and Collaborators
Democritus University of Thrace
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Savvas P. Tokmakidis, PhD Democritus University of Thrace
  More Information

Publications:

Responsible Party: Savvas P. Tokmakidis, Ph.D., Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT01580475     History of Changes
Other Study ID Numbers: EPEAEK - PYTHAGORAS II, 1328-5 PYTHAGORAS II
Study First Received: March 18, 2012
Last Updated: April 18, 2012
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Democritus University of Thrace:
glycemic control,
exercise training,
detraining,
retraining,
body composition,
strength and fitness

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

ClinicalTrials.gov processed this record on August 21, 2014