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הניסוי הקליני NCT07428746 (GLOW) עבור סוכרת סוג 2 הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes (GLOW) שלב III 20
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07428746 (GLOW) מתוכנן לבדוק את טיפול עבור סוכרת סוג 2. זהו מחקר שלב III מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 באפריל 2026, במטרה לכלול 20 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 בנובמבר 2028. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-24 בפברואר 2026.
סיכום קצר
The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes.
The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength.
Participants will:
- Receive GLP-1 RA therapy as part of their routine clinical care
- Complete muscle strength assessments (hand grip strength, Timed Up and...
תיאור מפורט
Older females with type 2 diabetes experience a disproportionately high burden of osteosarcopenia, a condition defined by the coexistence of low muscle mass, reduced muscle strength, and decreased bone mineral density. Osteosarcopenia is associated with increased risks of falls, fractures, functional decline, hospitalization, and loss of independence. Diabetes contributes to these risks through multiple mechanisms, i...הצג עוד
כותרת רשמית
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
מצבים רפואיים
סוכרת סוג 2מזהי מחקר נוספים
- GLOW
- 2025P013673
- K12AR084234 (מענק/חוזה של NIH בארה"ב)
מספר NCT
תחילת המחקר (בפועל)
2026-04
עדכון אחרון שפורסם
2026-02-24
סיום המחקר (מוערך)
2028-11
משתתפים (מתוכנן)
20
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
טרם החל גיוס
מילות מפתח
GLP-1 Receptor analogs
Semaglutide
DEXA
Osteosarcopenia
Bone Mineral Density
Bone turnover markers
Semaglutide
DEXA
Osteosarcopenia
Bone Mineral Density
Bone turnover markers
מטרה ראשית
טיפול
הקצאת טיפול
לא ישים
דגם מתערב
קבוצה יחידה
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיType 2 Diabetics on Semaglutide Participants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period. | Semaglutide Semaglutide is an FDA-approved drug for the treatment of T2D at the following doses (0.25, 0.5, 1, and 2 mg) that is self-administered weekly using an autoinjector pen.
The drug dosage will gradually increase every 4 weeks if tolerated to reach maintenance doses of 2 mg for semaglutide until the end of the study (6 months). If a participant cannot tolerate a dose, the highest tolerable dose will be administered, wit...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change in handgrip strength | Handgrip strength is a validated indicator of overall muscle strength and a core diagnostic component of sarcopenia. HGS will be assessed using a calibrated hydraulic hand dynamometer.
Output is recorded in kilograms (kg) of force. Higher values indicate greater muscle strength | Baseline, week4, week 8, week12, week 26. |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Change in bone turnover markers | Bone turnover markers (BTMs) reflect the rate of bone remodeling, including both bone formation and bone resorption processes. These laboratory biomarkers provide insight into dynamic skeletal changes that may occur during GLP-1 receptor agonist therapy.
BTMs may include:
* Bone formation markers (e.g., P1NP)
* Bone resorption markers (e.g., CTX) Results will be reported in standard laboratory units (e.g., ng/mL, µg/L), depending on the specific assay.
Higher formation markers indicate increased bone formation; higher resorption markers indicate increased bone breakdown | Baseline, 3 month, 6 months |
Change in timed up-and-go (TUG) | The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to rise from a standard chair, walk to a marked 10-foot line, turn around, return to the chair, and sit down.
Time is recorded in seconds (s).
* Shorter times indicate better functional mobility.
* Longer times may reflect impairments in balance, gait speed, or lower-extremity strength. | Baseline, week4, week 8, week12, week 26. |
Change in HbA1c | Collected via venous blood sample and analyzed using standardized laboratory assays.
HbA1c will be reported as a percentage (%). Reductions in HbA1c and fasting glucose reflect improved insulin sensitivity and glycemic regulation. | Baseline, 3 month, 6 months |
Change in fasting glucose | Measured after an overnight fast of at least 8 hours. Fasting glucose will be reported in mg/dL. Reductions in fasting glucose reflect improved insulin sensitivity and glycemic regulation | Baseline, 6 months |
Change in weight | Measured using a calibrated digital scale with participants wearing light clothing and no shoes.
Body weight will be reported in kilograms (kg).
Weight change (kg) will be calculated as the difference between baseline and follow-up measurements | Baseline, week4, week 8, week12, week 26. |
Change in FRAX score | Fracture risk will be evaluated using the FRAX algorithm, which integrates bone mineral density (BMD) at the femoral neck with validated clinical risk factors to estimate the 10-year probability of major osteoporotic fracture and hip fracture.
FRAX results are expressed as percent probabilities (%). Lower percentages indicate reduced fracture risk. | Baseline, 6 months |
Change in lipid profile | Serial lipid measurements will be collected to evaluate cardiovascular risk modification during GLP-1 receptor agonist therapy.
LDL-C, HDL-C, triglycerides, and total cholesterol will be reported in mg/dL.
* Change in each lipid parameter will be calculated as the difference between baseline and 6-month values.
* Lower LDL-C and triglycerides, along with higher HDL-C, indicate improved cardiovascular risk profiles. | Baseline, 3 months, 6 months |
Changes in exercise frequency | The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.
Responses are used to calculate the total weekly frequency of various activity categories.
Weekly frequency of each activity (number of sessions per week) | Baseline, 6 months |
Changes in exercise duration | The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire is a validated self-report tool designed to assess weekly frequency and duration of lifestyle physical activities commonly performed by older adults. It captures a broad range of activities across light, moderate, and vigorous intensities, providing a comprehensive estimate of habitual physical activity.
Responses are used to calculate the total weekly duration of various activity categories.
Higher values indicate greater physical activity engagement. | Baseline, 6 months |
Change in frailty assessment | Frailty will be assessed using a questionnaire based on the Fried phenotype, evaluating five components: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness. A structured data capture form modeled on the validated assessment will be used.
Assessment Procedure \& Scoring:
* Completed at baseline and 6 months.
* Each criterion is scored as present or absent (0-5 total).
* 0: Non-frail
* 1-2: Pre-frail
* ≥3: Frail
Interpretation:
Higher scores indicate greater frailty; changes over time reflect shifts in physiologic vulnerability. | Baseline, 6 months |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
גיל שלישי
גיל מינימלי למחקר
65 Years
מגדרים מוערכים למחקר
נקבה
- Postmenopausal women aged 65 years or older
- Has type 2 diabetes
- Body Mass Index (BMI) ≥27 kg/m² to max 40kg/m2 (inclusive)
- Hemoglobin A1c between 7-10% within 3 months of the first visit.
- Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
- No osteoporosis confirmed on DEXA scan within 12 months
- Able to provide informed consent and participate in all study assessments
- Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D
- eGFR <30 ml/min in the last 3 months
- Patients with a history of treatment with anti-osteoporosis agents
- Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies
- Documented presence of prosthesis or devices in the spine or hip
- Previous fragility fracture
- Males
- Moderate to severe gastroesophageal reflux disease based on patient history.
- Inability to comply with the treatment protocol or to understand the consent form.
- Aspartate aminotransferase (AST) > 3 times normal or alanine aminotransferase (ALT) > 3 times the normal
- Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.
- Personal or family history of medullary thyroid carcinoma.
- Personal or family history of multiple endocrine neoplasia type 2 syndrome.
- Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease
- Personal history of severe diabetic retinopathy.
- Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients.
- Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones or DPP-4 inhibitors
- Concomitant treatment with GLP-1 receptor agonist therapy
- Long-term intravenous, oral and intra-articular administration of high dose corticosteroids within 2 months before screening (more than 7 days in a row)
- Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage
- Incarcerated individuals
הגורם האחראי למחקר
Thaer Idrees, חוקר ראשי, Assistant Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Thaer Idrees, MD, FSSCI, 404-251-5357, [email protected]
איש קשר: Jaafer Zaino, [email protected]
1 מיקומי המחקר ב-1 מדינות
Georgia
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Thaer Idrees, MD, FSSCI, איש קשר, 404-251-5357, [email protected]
Thayer Idrees, MD, חוקר ראשי