Diet and Exercise Intervention in Type 2 Diabetes (LID)
13 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
18
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans à 68 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Skeletal muscle insulin sensitivity
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Liver insulin sensitivity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2013
Achèvement primaire (Réel)
1 juillet 2016
Achèvement de l'étude (Réel)
1 juillet 2016
Dates d'inscription aux études
Première soumission
14 octobre 2013
Première soumission répondant aux critères de contrôle qualité
30 octobre 2013
Première publication (Estimation)
6 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201302095
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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