رادار التجارب AI | ||
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حالة التجربة السريرية NCT07325435 (Beta) لـ Type 2 Diabetes (T2DM) هي نشط (لا يقبل مشاركين جدد). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists المرحلة الرابعة ٦٠ عشوائية قصير الأمد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07325435 (Beta) مصممة لدراسة علاج لـType 2 Diabetes (T2DM). إنها دراسة تدخُّلية من المرحلة الرابعة وهي نشط (لا يقبل مشاركين جدد). بدأت في ٢٠ جمادى الآخرة ١٤٤٦ هـ مع خطة لتجنيد ٦٠ مشاركًا. تقودها MaryAnn Banerji، ومن المتوقع اكتمالها بحلول ٧ صفر ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٩ رجب ١٤٤٧ هـ.
الملخص
Minorities have higher rates of diabetes, poorer glucose control, and higher complications and mortality rates than white people. Several recently approved diabetes medicines improve cardiovascular and renal outcomes through two different mechanisms. This study will explore key determinants of blood glucose levels namely beta cell function after short-term randomized, parallel group treatment with FDA approved Glucag...عرض المزيد
وصف مفصل
Approximately 200 black people with DM2 will be screened, then stabilized on diet and exercise alone, metformin alone or metformin plus a sulfonylurea. Following stabilization, those meeting study entry criteria will be offered the treatment study with 60 randomized to 4 months of treatment with GLP-1 RA or a SGLT-2i administered according to FDA approved guidelines. After an overnight fast, an oral glucose tolerance...عرض المزيد
العنوان الرسمي
Beta Cell Function in Type 2 Diabetes in Black Patients: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
الحالات الطبية
Type 2 Diabetes (T2DM)المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- Beta
- 1876088 SUNY Downstate Medical
- New York Community Trust (رقم منحة/تمويل آخر) (New York Community Trust)
NCT معرّف
تاريخ البدء (فعلي)
2024-12-21
آخر تحديث مُنشور
2026-01-08
تاريخ الاكتمال (المقدر)
2028-06-30
عدد المشاركين المخطط لهم
٦٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الرابعة
الحالة
نشط (لا يقبل مشاركين جدد)
الكلمات الرئيسية
Beta Cell Function
Type 2 diabetes
Black African American
Diabetes metabolism
GLP-1 receptor Agonist
SGLT-2 inhibitor
medication effects in Type 2 Diabetes
Type 2 diabetes
Black African American
Diabetes metabolism
GLP-1 receptor Agonist
SGLT-2 inhibitor
medication effects in Type 2 Diabetes
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطGLP1-RA We will examine the effect of GLP-1 RA on pancreatic beta cell function as measured by insulin, C-peptide and glucose serum concentrations during OGTT. | GLP1-RA GLP-1 RAs stimulate the GLP-1 Receptor |
مقارن نشطSGLT-2i We will examine the effect of SGLT-2i on pancreatic beta cell function as measured by insulin, C-peptide and glucose serum concentrations during OGTT | SGLT-2 inhibitor SGLT-2 inhibitors block the SGLT-2 receptor |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in Stimulated C-peptide Index during an Oral Glucose Tolerance Test is a measure of Beta Cell Function and will be measuresd at baseline and at 16 weeks after treatment with GLP-1 Receptor Agonist or SGLT2-Inhibitor | Primary Outcome Measure: The stimulated c-peptide index a primary outcome measure and is measured at baseline and 16 weeks. Change in the stimulated c-peptide index is the 16 week value minus the baseline.
Higher numbers of the c-peptide index indicate better beta cell function while lower numbers indicated worse beta cell function.
The stimulated c-peptide index is a calculated ratio of the c-peptide (ng/ml) to glucose levels (mg/dl) used to assess pancreatic beta cell function. It is calculated as the incremental area under the curve (AUC) of plasma C-peptide divided by the incremental AUC of plasma glucose (∆C-peptide 0-120/∆ Glucose 0-120). The outcome measure of plasma c-peptide (ng/ml) and plasma glucose (mg/dl), during the OGTT (after an overnight fast) at -15, 0, 10, 30, 45, 60, 90 and 120 minutes are combined into one primary outcome variable. | Baseline, 16 weeks |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
1 . Title: Change in Glycemic Control Measured at Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 Inhibitors | Description: The outcome measure for glycemic control is hemoglobin A1c (%) measured at baseline and at 16 weeks. Change in hemoglobin A1c is the 16 week value minus the baseline.
A negative change in hemoglobin A1c is an improvement in glucose control while a positive change suggests worsening outcomes. | Baseline, 16 weeks |
Change in Body Weight from Baseline and 16 Weeks of Treatment with GLP-1 receptor Agonist or SGLT-2 inhibitors | The outcome measure of body weight in Kg will be measured at baseline and 16 weeks. Change in body weight is the value at 16 weeks minus the baseline. A negative change in body weight is an improvement in weight while a positive change may suggest worsening body weight | Baseline, 16 weeks |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
24 Years
الجنس المؤهل
الكل
- Agrees to participate (signs and dates the informed consent) and agrees to all study procedures and conditions of the protocol.
- Black (self-identified) patients with relatively recent onset (< 15 years) DM2
- aged >= 24 years of age (adults < age 24 years old need additional resources to consistently participate, and may have different metabolism)
- HbA1c between 6.9% and 10%, inclusive
- BMI > 23 and < 45 kg/m2, and stable body weight over 2 months
- Currently taking no diabetes medication or on stable doses (2 months) of metformin or metformin plus sulfonylureas without additional diabetes medication(s).
- Ability to take and agree to taking oral medication and to self-inject
- For persons of reproductive potential: negative pregnancy test, use of effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation, and for an additional 4 weeks after completing the use of the study drug. They will be counseled that if they wish to become pregnant, they should follow the standard practice of optimizing their blood glucose in preparation for pregnancy. Use of these study drugs are not considered standard of care for diabetes during pregnancy. Effective contraception includes tubal ligation, hysterectomy, oral, implanted or injected contraceptives, mechanical (IUD) and barriers (diaphragm, condoms, spermicides) methods.
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study, including following a diabetic diet and maintaining a physical activity program
Exclusion Criteria:
- Poor general health, low kidney function (eGFR < 45), abnormal liver blood tests (AST and ALT > 3 times the ULN, Bilirubin 2 x ULN), serious cardiovascular, liver or renal disease, known proliferative retinopathy, type 1 diabetes, pancreatitis or pancreas cancer, medullary thyroid cancer, MEN2 (or family history of MEN2), current low hematocrit (< 35% for men and 33% for women, frailty, at risk for falls, current (past six months) alcohol or substance use disorder, history of a non-traumatic bone fracture, amputation, organ transplant, HIV or COVID, or if the patient cannot complete study activities.
- Current regular use of DDP-4 inhibitors, insulin or GLP-1 RA or SGLT2-inhibitors
- Currently pregnant, planned pregnancy in the next 7 months or nursing/lactating.
- Known allergic reactions to either the study medication
- Treatment with another investigational drug or other intervention within 4 months, or plan to enroll in another interventional study during their participation in this study
- Planned major surgery
- Recent (within 6 months): MI, Stroke, Cerebrovascular accident or unstable angina or revascularization procedures, grade 3 or 4 heart failure
- Use of weight loss medication, weight loss surgery.
- Use of glucocorticoids for chronic illness within 8 weeks prior to screening or likely to begin glucocorticoids during study period
- Study doctor considers subject a poor study candidate
- Cancer - History of active or untreated malignancy or in remission from a clinically significant malignancy for < 5 years; exception: basal cell carcinoma of the skin.
MaryAnn BanerjiThe New York Community Trustالجهة المسؤولة عن الدراسة
MaryAnn Banerji, الراعي-المحقق, Professor of Medicine, Endocrinologist, State University of New York - Downstate Medical Center
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
New York
SUNY Downstate Health Sciences University, Brooklyn, New York, 11203, United States