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NCT Number: NCT01580475

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

* 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Savvas P. Tokmakidis

Komotini, 691 00, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

Training - detraining - retraining

Other

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).

Primary outcomes

  1. 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)

    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 outcomes

  1. Evaluation of body composition

    Time frame: Changes from baseline in body composition assessment at training (9 months), detraining (3 months), retraining (9 months)

    Anthropometric Assessment: Body weight, height, BMI and waist circumference (WC).

  2. Peak oxygen consumption (VO2peak)

    Time frame: Changes from baseline in VO2peak at training (9 months), detraining (11 months) and retraining (21 months)

    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).

  3. 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)

    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.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Collaborators

  • Aristotle University Of Thessaloniki

Registry information

Official study title

Training, Detraining and Retraining Effects on Glycemic Control and Physical Fitness in Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Apr 19, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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