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| Name | Class |
|---|---|
| National Dairy Council | OTHER |
| American Egg Board | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines. |
|
| Intensive Lifestyle intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Lifestyle Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle insulin sensitivity | 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. | 7-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver insulin sensitivity | Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index. | 7-8 months |
| Adipose tissue insulin sensitivity | Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36084645 | Derived | 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. | |
| 34905513 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | 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). |
|
| 7-8 months |
| β-cell function | β-cell function will be assessed from a modified oral glucose tolerance test | 7-8 months |
| Insulin clearance | Insulin clearance will be assessed from a modified oral glucose tolerance test | 7-8 months |
| Diabetes remission | Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications. | 7-8 months |
| Cardiorespiratory fitness | Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion. | 7-8 months |
| Muscle strength | 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. | 7-8 months |
| Whole-body fat mass | Total body fat mass will be assessed by dual-energy X-ray absorptiometry. | 7-8 months |
| Whole-body fat-free mass | Fat-free mass will be assessed by dual-energy X-ray absorptiometry. | 7-8 months |
| Appendicular lean mass | Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry. | 7-8 months |
| Intra-abdominal adipose tissue volume | Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging. | 7-8 months |
| Intrahepatic triglyceride content | Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy. | 7-8 months |
| Plasma adipokine concentrations | Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory. | 7-8 months |
| Transcriptome in muscle and adipose tissue | The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques. | 7-8 months |
| Skeletal muscle mitochondrial metabolites | The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry. | 7-8 months |
| 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. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |