Diet and Exercise Intervention in Type 2 Diabetes (LID)
2022年4月13日 更新者: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.
研究概览
详细说明
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).
研究类型
介入性
注册 (实际的)
18
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 68年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Skeletal muscle insulin sensitivity
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Liver insulin sensitivity
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年10月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2013年10月14日
首先提交符合 QC 标准的
2013年10月30日
首次发布 (估计)
2013年11月6日
研究记录更新
最后更新发布 (实际的)
2022年4月15日
上次提交的符合 QC 标准的更新
2022年4月13日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.