Diet and Exercise Intervention in Type 2 Diabetes (LID)
13 april 2022 bijgewerkt door: Washington University School of Medicine
The purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
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
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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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
25 jaar tot 68 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Age 25-68 yrs old
- BMI 27.0-50.0 kg/m²
- Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
- HbA1C ≤9.5 %.
- Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.
Exclusion Criteria:
- Any change in diabetes medication in previous 3 months
- Treated with >0.5 units of insulin/kg body weight per day
- Unstable weight (>2% change during the last 2 months before entering the study)
- History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
- Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
- Creatinine >1.5 mg/dL
- Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
- Coagulation disorders
- Anemia (Hemoglobin <10.0 g/dL)
- Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
- Uncontrolled proliferative diabetic retinopathy
- Severe peripheral neuropathy diagnosed by monofilament testing
- Severe organ dysfunction
- Pregnant or breastfeeding
- Participating in regular exercise (>1 h of structured exercise/week)
- Joint replacement within the last year
- Smokes tobacco
- Severe lactose intolerance
- Take any medication that might interfere with interpretation of the metabolic studies
- Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
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: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Standard Care
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
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After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use.
Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study.
Any changes medications will made by the participants' personal physician(s).
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Experimenteel: Intensive Lifestyle intervention
Participants randomized to this arm will be participate in weekly dietary and behavioral education session in addition to four 60-min supervised exercise training sessions per week for 8 months.
All dietary and- behavioral education and exercise training sessions will be conducted at the worksite.
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Participants will be instructed to consume ~500 kcal/day less than their calculated estimated total daily energy requirements.
The supervised exercise program will include both endurance and resistance exercise training sessions.
The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Skeletal muscle insulin sensitivity
Tijdsspanne: 7-8 months
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Skeletal muscle insulin sensitivity will be calculated as the glucose disposal rate per kg fat-free mass divided by plasma insulin during a hyperinsulinemic-euglycemic clamp procedure.
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7-8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Liver insulin sensitivity
Tijdsspanne: 7-8 months
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Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
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7-8 months
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Adipose tissue insulin sensitivity
Tijdsspanne: 7-8 months
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Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
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7-8 months
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β-cell function
Tijdsspanne: 7-8 months
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β-cell function will be assessed from a modified oral glucose tolerance test
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7-8 months
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Insulin clearance
Tijdsspanne: 7-8 months
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Insulin clearance will be assessed from a modified oral glucose tolerance test
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7-8 months
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Diabetes remission
Tijdsspanne: 7-8 months
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Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.
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7-8 months
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Cardiorespiratory fitness
Tijdsspanne: 7-8 months
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Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
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7-8 months
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Muscle strength
Tijdsspanne: 7-8 months
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Muscle strength will be assessed as the total maximal weight lifted during the 1 repetition maximum tests for leg press, knee flexion, seated row, and chest press exercises.
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7-8 months
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Whole-body fat mass
Tijdsspanne: 7-8 months
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Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
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7-8 months
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Whole-body fat-free mass
Tijdsspanne: 7-8 months
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Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
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7-8 months
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Appendicular lean mass
Tijdsspanne: 7-8 months
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Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
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7-8 months
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Intra-abdominal adipose tissue volume
Tijdsspanne: 7-8 months
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Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
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7-8 months
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Intrahepatic triglyceride content
Tijdsspanne: 7-8 months
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Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
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7-8 months
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Plasma adipokine concentrations
Tijdsspanne: 7-8 months
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Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
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7-8 months
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Transcriptome in muscle and adipose tissue
Tijdsspanne: 7-8 months
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The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques.
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7-8 months
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Skeletal muscle mitochondrial metabolites
Tijdsspanne: 7-8 months
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The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
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7-8 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
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
- Yoshino M, Yoshino J, Smith GI, Stein RI, Bittel AJ, Bittel DC, Reeds DN, Sinacore DR, Cade WT, Patterson BW, Cho K, Patti GJ, Mittendorfer B, Klein S. Worksite-based intensive lifestyle therapy has profound cardiometabolic benefits in people with obesity and type 2 diabetes. Cell Metab. 2022 Oct 4;34(10):1431-1441.e5. doi: 10.1016/j.cmet.2022.08.012. Epub 2022 Sep 8.
- Mittendorfer B, Patterson BW, Smith GI, Yoshino M, Klein S. beta Cell function and plasma insulin clearance in people with obesity and different glycemic status. J Clin Invest. 2022 Feb 1;132(3):e154068. doi: 10.1172/JCI154068.
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 (Werkelijk)
1 oktober 2013
Primaire voltooiing (Werkelijk)
1 juli 2016
Studie voltooiing (Werkelijk)
1 juli 2016
Studieregistratiedata
Eerst ingediend
14 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
30 oktober 2013
Eerst geplaatst (Schatting)
6 november 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 april 2022
Laatste update ingediend die voldeed aan QC-criteria
13 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 201302095
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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