- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01580475
Training, Detraining, Retraining and Glycemic Control in Patients With Type 2 Diabetes
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Komotini, Grecia, 691 00
- Savvas P. Tokmakidis
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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%).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Lifestyle (exercise training)
Training, detraining and 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes from baseline in glycemic control measurements (follow-up for 21 months) at training (9 months), detraining (3 months) and retraining (9 months)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of body composition
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Savvas P. Tokmakidis, PhD, Democritus University of Thrace
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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. Erratum In: Med Sci Sports Exerc 2001 Jan;33(1):following table of contents.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EPEAEK - PYTHAGORAS II
- 1328-5 PYTHAGORAS II (Altro numero di sovvenzione/finanziamento: PYTHAGORAS II; co-financed by Hellenic (25%) and EC (75%))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Diabete di tipo 2
-
AmgenCompletato
-
Fudan UniversityShanghai Cancer Hospital, ChinaNon ancora reclutamento
-
Istituto Oncologico Veneto IRCCSReclutamentoGlioblastoma | Glioblastoma IDH wild-type e Stat3-positiviItalia
-
Oncology Institute of Southern SwitzerlandUniversity of Kiel; Ente Ospedaliero Cantonale, BellinzonaCompletato
-
Henan Cancer HospitalCompletatoCancro colorettale metastatico KRAS, NRAS e BRAF V600E wild-type
-
Hospital Universitari de BellvitgeInstitut d'Investigació Biomèdica de BellvitgeNon ancora reclutamentoArresto cardiaco | Cardiomiopatia amiloide | ATTR Amiloidosi Wild Type | Mutazione del gene ATTR
-
AmgenCompletatoCancro colorettale metastatico RAS wild-type
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatoBulimia nervosa | Comportamento impulsivo | Eliminazione (disturbi alimentari) | Problemi alimentari | Disturbi alimentari in adolescenza | Anoressia Nervosa/Bulimia | Anoressia in adolescenza | Anoressia Nervosa, Atipica | Anoressia Nervosa, Binge Eating/Purging TypeStati Uniti
-
Denver Health and Hospital AuthorityCompletatoDisturbo evitante restrittivo dell'assunzione di cibo | Anoressia Nervosa, Binge Eating/Purging Type | ARFIDE | Tipo restrittivo di anoressia nervosaStati Uniti
Prove cliniche su Training - detraining - retraining
-
Cardiology Research UBCSconosciuto
-
Università degli Studi dell'InsubriaRitiratoDisabilità intellettuale | Fisioterapia sportiva | Attività, Motore | Compromissione intellettiva
-
University of AberdeenNHS GrampianCompletato
-
US Department of Veterans AffairsUniversity of Maryland; National Institutes of Health (NIH); National Institute...CompletatoDiabete mellito di tipo 2 | Alterata tolleranza al glucosio (prediabete)Stati Uniti
-
University of JyvaskylaCompletatoEsercizio di formazione | Muscolo scheletrico | Atrofia muscolare scheletricaFinlandia
-
Vestre Viken Hospital TrustUniversitaire Ziekenhuizen KU Leuven; Jessa Hospital; St. Olavs Hospital; University... e altri collaboratoriReclutamentoFibrillazione atrialeNorvegia
-
University College DublinMater Misericordiae University Hospital; Irish Cancer SocietyReclutamentoDisagio psicologico | Recidiva del cancroIrlanda
-
Tuba MelekoğluCompletatoVariabilità del battito cardiaco | Grasso corporeo | Lotta | Test di idoneitàTacchino
-
University of ThessalyCompletatoComposizione corporea | Prestazione | Tasso metabolico a riposo | Attività fisica abituale | Intervallo di allenamento ad alta intensità basato su circuitoGrecia
-
University of FloridaTerminato