رادار التجارب AI | ||
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حالة التجربة السريرية NCT05585190 لـ مرحلة ما قبل السكري، السمنة، متلازمة الأيض، السلوك الخامل هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
Stand Up for Your Health with a Sit-stand Desk
The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses.
The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).
Stand Up for Your Health: a Randomized Study
- 44431
Obesity
Metabolic Syndrome
Cardiovascular
Sit-stand desk
Physical Activity
Overweight
Sedentary
Standing desk
Insulin resistance
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
أخرىControl Subjects will not receive a sit/stand desk for the duration of the study and will be asked to follow their normal work day routine. | التحكم No intervention. |
مقارن نشط2-Hour Group Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 2 hours each work day. | Sit-stand Desk at Work Subjects will receive a sit-stand desk at their work location. |
مقارن نشط3-Hour Group Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 3 hours each work day. | Sit-stand Desk at Work Subjects will receive a sit-stand desk at their work location. |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Insulin sensitivity (HOMA-IR) | Determine if use of a sit-stand desk improves insulin sensitivity and ascertain if there is a dose-response relationship with changes in sedentary time. | change from baseline to 6 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
HbA1c | Determine if use of a sit-stand desk improves HbA1c. | change from baseline to 6 months |
fasting glucose | Determine if use of a sit-stand desk improves fasting glucose. | change from baseline to 6 months |
fasting insulin level | Determine if use of a sit-stand desk improves (reduces) fasting insulin levels. | change from baseline to 6 months |
metabolic syndrome severity (MetS) score | Determine if use of a sit-stand desk at work improves metabolic health, as assessed by the MetS severity score, in sedentary office workers at-risk for type 2 diabetes mellitus. | change from baseline to 6 months |
metabolic syndrome | Determine if use of a sit-stand desk at work improves metabolic health, as assessed by number of (NCEP ATP III) metabolic syndrome criteria, in sedentary office workers at-risk for type 2 diabetes mellitus. | change from baseline to 6 months |
fasting triglycerides | To quantify changes in serum fasting triglyceride levels with the sit-stand desk (compared to no desk), while accounting for dietary intake. | change from baseline to 6 months |
very low-density lipoprotein (VLDL) particle number | To quantify changes in serum triglyceride-rich, remnant lipoproteins with the sit-stand desk (compared to no desk), while accounting for dietary intake. | change from baseline to 6 months |
vascular endothelial function (superficial femoral artery) | To measure the changes in vascular endothelial function with the sit-stand desk compared to control. | change from baseline to 6 months |
Overweight or obese (body mass index of 25 kg/m2 or higher)
Employees with "sedentary" jobs, defined as spending at least 75% of their (8 hours or more) workday sitting at a desk (at home or in an office)
Defined as "at-risk" for diabetes, defined as either:
Prediabetes (HbA1c of 5.7% to 6.4%) or a fasting glucose of 100 to 125 mg/dL
Having one or more additional risk factors: (beyond BMI>25)
- Age 45 years or older
- Family history of diabetes mellitus in a first-degree relative
- Physical inactivity (no structured exercise activity)
- History of gestational diabetes, hypertension, or dyslipidemia
- African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, Native Hawaiian, or Pacific Islander ethnicity
- Established cardiovascular disease (myocardial infarction, coronary stent, coronary artery bypass grafting, cardiac transplant, or angina)
- Established congestive heart failure or cardiomyopathy
- Established peripheral vascular disease
- Established diabetes (HbA1c ≥ 6.5% or on diabetes medications or insulin)
- Chronic musculoskeletal disorders involving the lower extremities, such as arthritis of the knees or hips, or regular use of ambulatory assist devices such as a walker or cane
- Neuropathy of any etiology
- Positional syncope or history of orthostasis
- Less than 4 days/week at any single office (or work-from-home) location.
- Current use of a standing desk for work
- Tobacco use within the previous 12 months
- Current illicit drug use or excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
- Steroid use ≥21 days/year
- Fasting triglyceride level ≥ 500 mg/dL
- Thyroid disease
- Uncontrolled or untreated hypertension(>150/90 mm Hg)
- Pregnant or lactating (or plans to become pregnant in the next 6 months)
- LDL cholesterol ≥ 190mg/dL
- Currently enrolled or plans to diet or join a weight loss program over the next 6 months.
- Non-English speaker
Wisconsin