A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes
21. desember 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
23
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
Andre navn:
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.
Andre navn:
|
|
Aktiv komparator: 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.
Andre navn:
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Glycated Hemoglobin (HbA1c) at 6 months
Tidsramme: 6 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.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Resting Metabolic Rate at 3 months
Tidsramme: 3 months
|
Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
|
3 months
|
|
Change from baseline Resting Metabolic Rate at 6 months
Tidsramme: 6 months
|
Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
|
6 months
|
|
Change from baseline Resting Metabolic Rate at 12 months
Tidsramme: 12 months
|
Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures
|
12 months
|
|
Change from baseline Body mass index at 3 months
Tidsramme: 3 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.
|
3 months
|
|
Change from baseline Body mass index at 6 months
Tidsramme: 6 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.
|
6 months
|
|
Change from baseline Body mass index at 12 months
Tidsramme: 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.
|
12 months
|
|
Change from baseline Fat-free mass at 3 months
Tidsramme: 3 months
|
Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
3 months
|
|
Change from baseline Fat-free mass at 6 months
Tidsramme: 6 months
|
Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
6 months
|
|
Change from baseline Fat-free mass at 12 months
Tidsramme: 12 months
|
Fat mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
12 months
|
|
Change from baseline android to gynoid percent fat ratio at 3 months
Tidsramme: 3 months
|
Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
3 months
|
|
Change from baseline android to gynoid percent fat ratio at 6 months
Tidsramme: 6 months
|
Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
6 months
|
|
Change from baseline android to gynoid percent fat ratio at 12 months
Tidsramme: 12 months
|
Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.).
|
12 months
|
|
Change from baseline fasting plasma glucose at 3 months
Tidsramme: 3 months
|
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.
|
3 months
|
|
Change from baseline fasting plasma glucose at 6 months
Tidsramme: 6 months
|
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.
|
6 months
|
|
Change from baseline fasting plasma glucose at 12 months
Tidsramme: 12 months
|
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.
|
12 months
|
|
Change from baseline HDL cholesterol at 3 months
Tidsramme: 3 months
|
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.
|
3 months
|
|
Change from baseline HDL cholesterol at 6 months
Tidsramme: 6 months
|
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.
|
6 months
|
|
Change from baseline HDL cholesterol at 12 months
Tidsramme: 12 months
|
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.
|
12 months
|
|
Change from baseline total cholesterol at 3 months
Tidsramme: 3 months
|
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.
|
3 months
|
|
Change from baseline total cholesterol at 6 months
Tidsramme: 6 months
|
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.
|
6 months
|
|
Change from baseline total cholesterol at 12 months
Tidsramme: 12 months
|
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.
|
12 months
|
|
Change from baseline triglycerides levels at 3 months
Tidsramme: 3 months
|
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.
|
3 months
|
|
Change from baseline triglycerides levels at 6 months
Tidsramme: 6 months
|
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.
|
6 months
|
|
Change from baseline triglycerides levels at 12 months
Tidsramme: 12 months
|
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.
|
12 months
|
|
Change from baseline serum creatinine at 3 months
Tidsramme: 3 months
|
Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
|
3 months
|
|
Change from baseline serum creatinine at 6 months
Tidsramme: 6 months
|
Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
|
6 months
|
|
Change from baseline serum creatinine at 12 months
Tidsramme: 12 months
|
Serum creatinine will be assessed from venous blood samples following standard quality-control procedures.
|
12 months
|
|
Change from baseline urinary albumin-to-creatinine ratio at 3 months
Tidsramme: 3 months
|
Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
|
3 months
|
|
Change from baseline urinary albumin-to-creatinine ratio at 6 months
Tidsramme: 6 months
|
Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
|
6 months
|
|
Change from baseline urinary albumin-to-creatinine ratio at 12 months
Tidsramme: 12 months
|
Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures.
|
12 months
|
|
Change from baseline maximal aerobic power at 3 months
Tidsramme: 3 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.
|
3 months
|
|
Change from baseline maximal aerobic power at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Francesco Zurlo, MD, University of Padova
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2013
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
26. oktober 2018
Først innsendt som oppfylte QC-kriteriene
21. desember 2018
Først lagt ut (Faktiske)
24. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2718P
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Type 2 diabetes mellitus
-
University Hospital Inselspital, BerneFullført
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Fullført
-
US Department of Veterans AffairsAmerican Diabetes AssociationFullførtType 2 diabetes mellitusForente stater
-
Dexa Medica GroupFullførtType-2 diabetes mellitusIndonesia
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Har ikke rekruttert ennåT2DM (type 2 diabetes mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (type 2 diabetes mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiFullført
Kliniske studier på Caloric restriction
-
University of KentFullført
-
Mayo ClinicFullført
-
Lauren EricksonAmerican College of Sports MedicineFullførtPatellofemoralt syndromForente stater
-
Cairo UniversityRekrutteringOvervekt | Irritabel tarm-syndrom | Abdominal fedmeEgypt
-
UMC UtrechtFullført
-
AspetarRekrutteringPatellofemoralt smertesyndrom | Kronisk knesmerter | Rotator cuff tendinose | Rotator Cuff Impingement Syndrome | Fremre knesmerter syndromQatar
-
Udayana UniversityRekrutteringSunne fag | Sport nivå 1Indonesia
-
Candice Dunkin, MS, LAT, ATCParkview HealthRekruttering