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رادار التجارب AI
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.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

Stand Up for Your Health with a Sit-stand Desk

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05585190 هي دراسة تدخُّلية لـمرحلة ما قبل السكري، السمنة، متلازمة الأيض، السلوك الخامل وهي قيد التجنيد. بدأت في ١٥ رجب ١٤٤٤ هـ مع خطة لتجنيد ١٩٨ مشاركًا. يقودها Medical College of Wisconsin، ومن المتوقع اكتمالها بحلول ٣ شعبان ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٤ رمضان ١٤٤٦ هـ.
الملخص
More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial.

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).

العنوان الرسمي

Stand Up for Your Health: a Randomized Study

الحالات الطبية
مرحلة ما قبل السكريالسمنةمتلازمة الأيضالسلوك الخامل
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • 44431
NCT معرّف
تاريخ البدء (فعلي)
2023-02-06
آخر تحديث مُنشور
2025-03-14
تاريخ الاكتمال (المقدر)
2027-12-31
عدد المشاركين المخطط لهم
١٩٨
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
Pre Diabetes
Obesity
Metabolic Syndrome
Cardiovascular
Sit-stand desk
Physical Activity
Overweight
Sedentary
Standing desk
Insulin resistance
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/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.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار 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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار 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
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  1. Overweight or obese (body mass index of 25 kg/m2 or higher)

  2. 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)

  3. Defined as "at-risk" for diabetes, defined as either:

    1. Prediabetes (HbA1c of 5.7% to 6.4%) or a fasting glucose of 100 to 125 mg/dL

    2. 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

  1. Established cardiovascular disease (myocardial infarction, coronary stent, coronary artery bypass grafting, cardiac transplant, or angina)
  2. Established congestive heart failure or cardiomyopathy
  3. Established peripheral vascular disease
  4. Established diabetes (HbA1c ≥ 6.5% or on diabetes medications or insulin)
  5. 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
  6. Neuropathy of any etiology
  7. Positional syncope or history of orthostasis
  8. Less than 4 days/week at any single office (or work-from-home) location.
  9. Current use of a standing desk for work
  10. Tobacco use within the previous 12 months
  11. Current illicit drug use or excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
  12. Steroid use ≥21 days/year
  13. Fasting triglyceride level ≥ 500 mg/dL
  14. Thyroid disease
  15. Uncontrolled or untreated hypertension(>150/90 mm Hg)
  16. Pregnant or lactating (or plans to become pregnant in the next 6 months)
  17. LDL cholesterol ≥ 190mg/dL
  18. Currently enrolled or plans to diet or join a weight loss program over the next 6 months.
  19. Non-English speaker
Medical College of Wisconsin logoMedical College of Wisconsin
الجهة المسؤولة عن الدراسة
Jacquelyn Kulinski, المحقق الرئيسي, Principal Investigator, Associate Professor, Medical College of Wisconsin
جهة اتصال مركزية للدراسة
جهة اتصال: Jacquelyn Kulinski, MD, 414-955-6896, [email protected]
جهة اتصال: Ryan Kacala, 414-955-6885, [email protected]
1 مواقع الدراسة في 1 بلدان

Wisconsin

Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Jacquelyn P Kulinski, MD, جهة اتصال, 414-955-6896, [email protected]
Ryan Kacala, جهة اتصال, 414-955-6885, [email protected]
قيد التجنيد