NCT01580475

Brief Summary

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

March 18, 2012

Last Update Submit

April 18, 2012

Conditions

Keywords

glycemic control,exercise training,detraining,retraining,body composition,strength and fitness

Outcome Measures

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)

    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).

    Changes from baseline in HbA1C, FPG and PPG at training (9 months), detraining (11 months) and retraining (21 months)

Secondary Outcomes (3)

  • Evaluation of body composition

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

  • Peak oxygen consumption (VO2peak)

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

  • Measurement of muscular strength in patients with type 2 diabetes

    Changes from baseline in muscular strength at training (9 months), detraining (11 months) and retraining (21 months)

Study Arms (1)

Lifestyle (exercise training)

EXPERIMENTAL

Training, detraining and retraining

Other: Training - detraining - retraining

Interventions

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).

Lifestyle (exercise training)

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • without micro- and macroangiopathy

You may not qualify if:

  • type 1 diabetes
  • cardiovascular disease,
  • confirmed retinopathy/nephropathy/neuropathy,
  • uncontrolled diabetes mellitus (HbA1c\>10%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Savvas P. Tokmakidis

Komotini, 691 00, Greece

Location

Related Publications (6)

  • Tokmakidis SP, Zois CE, Volaklis KA, Kotsa K, Touvra AM. The effects of a combined strength and aerobic exercise program on glucose control and insulin action in women with type 2 diabetes. Eur J Appl Physiol. 2004 Aug;92(4-5):437-42. doi: 10.1007/s00421-004-1174-6.

    PMID: 15232701BACKGROUND
  • Tokmakidis SP, Volaklis KA. Training and detraining effects of a combined-strength and aerobic exercise program on blood lipids in patients with coronary artery disease. J Cardiopulm Rehabil. 2003 May-Jun;23(3):193-200. doi: 10.1097/00008483-200305000-00006.

    PMID: 12782903BACKGROUND
  • Tokmakidis SP, Spassis AT, Volaklis KA. Training, detraining and retraining effects after a water-based exercise program in patients with coronary artery disease. Cardiology. 2008;111(4):257-64. doi: 10.1159/000127737. Epub 2008 Apr 23.

    PMID: 18434735BACKGROUND
  • American College of Sports Medicine; American Dietetic Association; Dietitians of Canada. Joint Position Statement: nutrition and athletic performance. American College of Sports Medicine, American Dietetic Association, and Dietitians of Canada. Med Sci Sports Exerc. 2000 Dec;32(12):2130-45. doi: 10.1097/00005768-200012000-00025.

    PMID: 11128862BACKGROUND
  • Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.

    PMID: 12453982BACKGROUND
  • Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.

    PMID: 12351469BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Savvas P. Tokmakidis, PhD

    Democritus University of Thrace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2012

First Posted

April 19, 2012

Study Start

September 1, 2008

Primary Completion

September 1, 2008

Study Completion

June 1, 2010

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations