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رادار التجارب AI
حالة التجربة السريرية NCT06180837 لـ عوامل نمط الحياة، زيادة الوزن والسمنة، حساسية الأنسولين، عادات الأكل، نظافة النوم، داء السكري من النوع 2، النوم، الحرمان من النوم، متلازمة نقص النوم 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
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Effect of Sleep Extension on Ceramides in People with Overweight and Obesity

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 NCT06180837 هي دراسة تدخُّلية لـعوامل نمط الحياة، زيادة الوزن والسمنة، حساسية الأنسولين، عادات الأكل، نظافة النوم، داء السكري من النوع 2، النوم، الحرمان من النوم، متلازمة نقص النوم وهي قيد التجنيد. بدأت في ٢ شعبان ١٤٤٥ هـ مع خطة لتجنيد ٧٠ مشاركًا. يقودها جامعة يوتا، ومن المتوقع اكتمالها بحلول ٤ شعبان ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٩ جمادى الآخرة ١٤٤٦ هـ.
الملخص
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
وصف مفصل
A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted. Group allocation will be 1:1 and research staff and participants will be blinded until the conclusion of the baseline segment. The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night. Participants randomized to control will maintain their habitual sleep habits in their home environment. The intervention segment will last 8 weeks regardless of group assignment. Both groups will have equal contact time with the study team.

Prior to enrollment participants will complete a clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment). Throughout the study, sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides (targeted metabolomics assay) and insulin sensitivity (hyperinsulinemic-euglycemic clamp).

العنوان الرسمي

Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk

الحالات الطبية
عوامل نمط الحياةزيادة الوزن والسمنةحساسية الأنسولينعادات الأكلنظافة النومداء السكري من النوع 2النومالحرمان من النوممتلازمة نقص النوم
معرّفات دراسة أخرى
  • 164764
NCT معرّف
NCT06180837
تاريخ البدء (فعلي)
2024-02-12
آخر تحديث مُنشور
2024-12-20
تاريخ الاكتمال (المقدر)
2028-01
عدد المشاركين المخطط لهم
٧٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
sleep
insulin sensitivity
الغرض الأساسي
وقاية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
بدون تدخلControl Group
Provided with general health information on diet and physical activity.
غ/م
تجريبيةIntervention Group
Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.
Sleep Extension Intervention
Sleep extension-based intervention focused on increasing time spent in bed by 2 hours per night by directly scheduling assigned bed and waketimes based on participant's individual schedules. Participants will receive weekly sleep tips and counseling on improving their sleep duration.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Total Plasma Ceramides
Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.
Immediately after the intervention
Insulin Sensitivity
Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.
Immediately after the intervention
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Average (per week) nightly total sleep time (change from baseline)
Wrist-actigraphy
Analyzed as change from baseline for each week of the ~8 week experimental segment
Average (per week) sleep satisfaction change from baseline
5 point likert scale on daily sleep log (1 = very good; 5 = very poor)
Analyzed as change from baseline for each week of the ~8 week experimental segment
Average (per week) timing of food intake change from baseline
Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of two weekdays and one weekend day
During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
Average (per week) daytime alertness change from baseline
5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)
Time Frame: Analyzed as change from baseline for each week of the ~8 week experimental segment
Individual C16, C18, C20, C22, C24, and C24:1 Plasma Ceramides, Dihydroceramides, Glucosylceramides, and fourteen Sphingolipids.
Targeted metabolomics assay, 32 total metabolites.
Immediately after the intervention
Circadian Phase (change from baseline)
dim-light melatonin onset quantified from salivary melatonin samples
Immediately after the intervention
Body Mass Index
Nurses will collect height and body weight using standard procedures.
Immediately after the intervention
Cardiac Event Risk Test 1 (CERT 1)
The Cardiac Event Risk Test 1 (CERT1) is used to evaluate the risk of major adverse cardiovascular events and can be calculated using data from our targeted metabolomics assay. The scale is from 0-12, 0 being the lowest risk and 12 being the highest level of risk.
Immediately after the intervention
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
  1. Age: 18-45 years old; equal numbers of men and women
  2. Body mass index (BMI): 27.5-34.9 kg/m2
  3. Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months

  1. Clinically diagnosed sleep disorder or major psychiatric illness
  2. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
  3. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
  4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
  5. Cancer that has been in remission less than 5 years
  6. Pregnant/nursing, experiencing menopause or post-menopausal
  7. Shift-work: current or history of within last year
  8. Weight change: >10% of body weight over prior six months
  9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
  10. Currently smoking
  11. Alcohol intake>14 drinks per week or >3 drinks per day
University of Utah logoجامعة يوتا306 تجارب سريرية نشطة للاستكشاف
الجهة المسؤولة عن الدراسة
Christopher Depner, المحقق الرئيسي, Assistant Professor, University of Utah
جهة اتصال مركزية للدراسة
جهة اتصال: Christopher M Depner, PhD, 801-581-2275, [email protected]
1 مواقع الدراسة في 1 بلدان

Utah

College of Health Research Complex--University of Utah, Salt Lake City, Utah, 84112, United States
Christopher Depner, جهة اتصال, 8015812275, [email protected]
قيد التجنيد