A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes
21 dicembre 2018 aggiornato da: University of Padova
A Randomized Trial Evaluating the Effects of One-Year Caloric Restriction and 12-Week Exercise Training Intervention in Obese Adults With Type 2 Diabetes: Emphasis on Metabolic Control and Resting Metabolic Rate
Diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR).
Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight.
However, only few studies investigated how exercise could influence patients' RMR and results are still not unanimous.
In this study, we aim to investigate the effects on metabolic health of a combined dietary intervention and 12-week exercise training in obese adults with type 2 diabetes.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Although a number of exercise training interventions have been proposed to type 2 diabetes patients, the current clinical practice demonstrates that most patients are still sedentary and with excess body weight. A negative balance between energy intake and energy expenditure is crucial to reduce excess body weight. However, diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, no robust evidence has been collected on this issue, and the few studies that investigated how exercise could influence patients' RMR have not shown unanimous results, especially concerning combined dietary and physical activity interventions.
This open-label randomized trial in obese adults with type 2 diabetes aims to investigate the effects of a 1-year caloric restriction and 12-week exercise training intervention on metabolic health, RMR and VO2max.
In particular, eligible type 2 diabetes patients of our clinic will be invited to participate in a short lifestyle intervention (LSI). LSI will consist of four weekly group-led lessons lasting 60-90 minutes in which specialized professionals will educate patients on specific dietary and physical activity recommendations for improving health and metabolic control.
After this month, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.
Type 2 diabetic and obese adult volunteers will be recruited and screened through medical history, physical examination and biochemical analyses.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
23
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 30 anni a 64 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Signed informed consent
- age 30 to 64 years
- less than 60 min aerobic exercise/week
- absence of acute diseases
- no current treatment with insulin or sulfonylureas
Exclusion Criteria:
- Body mass index (BMI)<28
- HbA1c<6%
- Recent acute diseases, severe infections, trauma or surgery
- Uncontrolled hypertension or hyperglycemia
- Evidence of advanced cardiovascular, renal or hepatic diseases
- Contraindication to exercise
- Body weight change of more than 3% within the last 6 months
- Medication changes within the last 3 months
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Caloric restriction and early SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control.
At the end of the 1-month LSI, participants will start a caloric restriction and early exercise training (SSET) during the first 12-week, followed by no exercise at health centers for 3 months.
Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
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A structured dietary training will be implemented to educate participants about recommended dietary habits.Patients will follow a caloric restriction (CR) diet, with an energy intake equal to the measured Resting Metabolic Rate (RMR) and with 45% carbohydrate, 20%protein, 35%fat, and 30 g/day fibers.
At each follow-up, nutritionist will adjust CR to the latest measured RMR and assess the compliance to the diet.
Altri nomi:
Trainers will supervise participants during 12-weeks of structured exercise consisting of 150 min/week workouts, divided in three sessions of progressive mixed (aerobic and resistance) exercise.
All aerobic exercise will be performed using treadmill and/or cycle ergo-meter.
Altri nomi:
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Comparatore attivo: Caloric restriction and late SSET
Patients will participate to a short lifestyle intervention (LSI), consisting of four weekly group-led lessons lasting 60-90 minutes to educate them on specific dietary and physical activity recommendations for improving health and metabolic control.
At the end of the 1-month LSI, participants will start a one-year caloric restriction with no exercise at health centers for 3 months, and then a 12-week exercise training (SSET).
Between the 6- and the 12-month assessments, participants will continue caloric restriction and will be encouraged to freely exercise.
|
A structured dietary training will be implemented to educate participants about recommended dietary habits.Patients will follow a caloric restriction (CR) diet, with an energy intake equal to the measured Resting Metabolic Rate (RMR) and with 45% carbohydrate, 20%protein, 35%fat, and 30 g/day fibers.
At each follow-up, nutritionist will adjust CR to the latest measured RMR and assess the compliance to the diet.
Altri nomi:
Trainers will supervise participants during 12-weeks of structured exercise consisting of 150 min/week workouts, divided in three sessions of progressive mixed (aerobic and resistance) exercise.
All aerobic exercise will be performed using treadmill and/or cycle ergo-meter.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline Glycated Hemoglobin (HbA1c) at 6 months
Lasso di tempo: 6 months
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Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline Resting Metabolic Rate at 3 months
Lasso di tempo: 3 months
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Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
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3 months
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Change from baseline Resting Metabolic Rate at 6 months
Lasso di tempo: 6 months
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Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
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6 months
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Change from baseline Resting Metabolic Rate at 12 months
Lasso di tempo: 12 months
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Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
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12 months
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Change from baseline Body mass index at 3 months
Lasso di tempo: 3 months
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Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes.
Body mass index will be computed from the ratio between weight (kg) and height (m) squared.
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3 months
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Change from baseline Body mass index at 6 months
Lasso di tempo: 6 months
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Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes.
Body mass index will be computed from the ratio between weight (kg) and height (m) squared.
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6 months
|
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Change from baseline Body mass index at 12 months
Lasso di tempo: 12 months
|
Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes.
Body mass index will be computed from the ratio between weight (kg) and height (m) squared.
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12 months
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Change from baseline Fat-free mass at 3 months
Lasso di tempo: 3 months
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Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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3 months
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Change from baseline Fat-free mass at 6 months
Lasso di tempo: 6 months
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Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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6 months
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Change from baseline Fat-free mass at 12 months
Lasso di tempo: 12 months
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Fat mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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12 months
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Change from baseline android to gynoid percent fat ratio at 3 months
Lasso di tempo: 3 months
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Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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3 months
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Change from baseline android to gynoid percent fat ratio at 6 months
Lasso di tempo: 6 months
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Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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6 months
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Change from baseline android to gynoid percent fat ratio at 12 months
Lasso di tempo: 12 months
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Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
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12 months
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Change from baseline fasting plasma glucose at 3 months
Lasso di tempo: 3 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.
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3 months
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Change from baseline fasting plasma glucose at 6 months
Lasso di tempo: 6 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.
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6 months
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Change from baseline fasting plasma glucose at 12 months
Lasso di tempo: 12 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures.
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12 months
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Change from baseline HDL cholesterol at 3 months
Lasso di tempo: 3 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.
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3 months
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Change from baseline HDL cholesterol at 6 months
Lasso di tempo: 6 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.
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6 months
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Change from baseline HDL cholesterol at 12 months
Lasso di tempo: 12 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures.
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12 months
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Change from baseline total cholesterol at 3 months
Lasso di tempo: 3 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.
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3 months
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Change from baseline total cholesterol at 6 months
Lasso di tempo: 6 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.
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6 months
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Change from baseline total cholesterol at 12 months
Lasso di tempo: 12 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures.
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12 months
|
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Change from baseline triglycerides levels at 3 months
Lasso di tempo: 3 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.
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3 months
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Change from baseline triglycerides levels at 6 months
Lasso di tempo: 6 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.
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6 months
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Change from baseline triglycerides levels at 12 months
Lasso di tempo: 12 months
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Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures.
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12 months
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Change from baseline serum creatinine at 3 months
Lasso di tempo: 3 months
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Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
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3 months
|
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Change from baseline serum creatinine at 6 months
Lasso di tempo: 6 months
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Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
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6 months
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Change from baseline serum creatinine at 12 months
Lasso di tempo: 12 months
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Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
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12 months
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Change from baseline urinary albumin-to-creatinine ratio at 3 months
Lasso di tempo: 3 months
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Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
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3 months
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Change from baseline urinary albumin-to-creatinine ratio at 6 months
Lasso di tempo: 6 months
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Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
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6 months
|
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Change from baseline urinary albumin-to-creatinine ratio at 12 months
Lasso di tempo: 12 months
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Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
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12 months
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Change from baseline maximal aerobic power at 3 months
Lasso di tempo: 3 months
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VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.
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3 months
|
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Change from baseline maximal aerobic power at 6 months
Lasso di tempo: 6 months
|
VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.
|
6 months
|
|
Change from baseline maximal aerobic power at 12 months
Lasso di tempo: 12 months
|
VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol.
|
12 months
|
|
Change from baseline Glycated Hemoglobin (HbA1c) at 3 months
Lasso di tempo: 3 months
|
Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.
|
3 months
|
|
Change from baseline Glycated Hemoglobin (HbA1c) at 12 months
Lasso di tempo: 12 months
|
Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures.
|
12 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Francesco Zurlo, MD, University of Padova
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Alawad AO, Merghani TH, Ballal MA. Resting metabolic rate in obese diabetic and obese non-diabetic subjects and its relation to glycaemic control. BMC Res Notes. 2013 Sep 26;6:382. doi: 10.1186/1756-0500-6-382.
- Stevenson RW, Parsons JA, Alberti KG. Effect of intraportal and peripheral insulin on glucose turnover and recycling in diabetic dogs. Am J Physiol. 1983 Feb;244(2):E190-5. doi: 10.1152/ajpendo.1983.244.2.E190.
- Zawadzki JK, Wolfe RR, Mott DM, Lillioja S, Howard BV, Bogardus C. Increased rate of Cori cycle in obese subjects with NIDDM and effect of weight reduction. Diabetes. 1988 Feb;37(2):154-9. doi: 10.2337/diab.37.2.154.
- Piaggi P, Thearle MS, Bogardus C, Krakoff J. Fasting hyperglycemia predicts lower rates of weight gain by increased energy expenditure and fat oxidation rate. J Clin Endocrinol Metab. 2015 Mar;100(3):1078-87. doi: 10.1210/jc.2014-3582. Epub 2015 Jan 5.
- Araiza P, Hewes H, Gashetewa C, Vella CA, Burge MR. Efficacy of a pedometer-based physical activity program on parameters of diabetes control in type 2 diabetes mellitus. Metabolism. 2006 Oct;55(10):1382-7. doi: 10.1016/j.metabol.2006.06.009.
- Jennings AE, Alberga A, Sigal RJ, Jay O, Boule NG, Kenny GP. The effect of exercise training on resting metabolic rate in type 2 diabetes mellitus. Med Sci Sports Exerc. 2009 Aug;41(8):1558-65. doi: 10.1249/MSS.0b013e31819d6a6f.
- Mourier A, Gautier JF, De Kerviler E, Bigard AX, Villette JM, Garnier JP, Duvallet A, Guezennec CY, Cathelineau G. Mobilization of visceral adipose tissue related to the improvement in insulin sensitivity in response to physical training in NIDDM. Effects of branched-chain amino acid supplements. Diabetes Care. 1997 Mar;20(3):385-91. doi: 10.2337/diacare.20.3.385.
- Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
- Zurlo F, Trevisan C, Vitturi N, Ravussin E, Salvo C, Carraro S, Siffi M, Iob I, Saller A, Previato L, Sergi G, de Kreutzenberg S, Maran A, Avogaro A. One-year caloric restriction and 12-week exercise training intervention in obese adults with type 2 diabetes: emphasis on metabolic control and resting metabolic rate. J Endocrinol Invest. 2019 Dec;42(12):1497-1507. doi: 10.1007/s40618-019-01090-x. Epub 2019 Jul 29.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2013
Completamento primario (Effettivo)
1 ottobre 2015
Completamento dello studio (Effettivo)
1 ottobre 2015
Date di iscrizione allo studio
Primo inviato
26 ottobre 2018
Primo inviato che soddisfa i criteri di controllo qualità
21 dicembre 2018
Primo Inserito (Effettivo)
24 dicembre 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 dicembre 2018
Ultimo verificato
1 dicembre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2718P
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
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 .