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

18 april 2012 bijgewerkt door: Savvas P. Tokmakidis, Ph.D., Democritus University of Thrace

Training, Detraining and Retraining Effects on Glycemic Control and Physical Fitness 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

13

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Griekenland
      • Komotini, Griekenland, 691 00
        • Savvas P. Tokmakidis

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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%).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Lifestyle (exercise training)
Training, detraining and retraining
Ander: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes from baseline in glycemic control measurements (follow-up for 21 months) at training (9 months), detraining (3 months) and retraining (9 months)
Tijdsspanne: 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).
Changes from baseline in HbA1C, FPG and PPG at training (9 months), detraining (11 months) and retraining (21 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of body composition
Tijdsspanne: 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).
Changes from baseline in body composition assessment at training (9 months), detraining (3 months), retraining (9 months)
Peak oxygen consumption (VO2peak)
Tijdsspanne: 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).
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
Tijdsspanne: 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.
Changes from baseline in muscular strength at training (9 months), detraining (11 months) and retraining (21 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Democritus University of Thrace

Medewerkers

Aristotle University Of Thessaloniki

Onderzoekers

  • Hoofdonderzoeker: Savvas P. Tokmakidis, PhD, Democritus University of Thrace

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2008

Primaire voltooiing (Werkelijk)

1 september 2008

Studie voltooiing (Werkelijk)

1 juni 2010

Studieregistratiedata

Eerst ingediend

18 maart 2012

Eerst ingediend dat voldeed aan de QC-criteria

18 april 2012

Eerst geplaatst (Schatting)

19 april 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

19 april 2012

Laatste update ingediend die voldeed aan QC-criteria

18 april 2012

Laatst geverifieerd

1 april 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EPEAEK - PYTHAGORAS II
  • 1328-5 PYTHAGORAS II (Ander subsidie-/financieringsnummer: PYTHAGORAS II; co-financed by Hellenic (25%) and EC (75%))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Type 2 diabetes

Klinische onderzoeken op Training - detraining - retraining

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