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הניסוי הקליני NCT07493707 (Apple vinegar) עבור Type 2 Diabetes Mellitus 2 הוא פעיל, לא מגייס. 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
Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus (Apple vinegar) 38 אקראי מחקר מוצלב תווית פתוחה
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 NCT07493707 (Apple vinegar) הוא מחקר מסוג התערבותי עבור Type 2 Diabetes Mellitus 2, שנמצא כעת במצב פעיל, לא מגייס. המחקר התחיל ב-6 במאי 2024 ומתוכנן לכלול 38 משתתפים. המחקר מנוהל על ידי Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran וצפוי להסתיים ב-1 בדצמבר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-25 במרץ 2026.
סיכום קצר
The objective of this open-label, randomized, crossover clinical trial is to determine the effect of consuming 15 ml of organic apple cider vinegar on glycemic variability, measured by the coefficient of variation of glucose, in adults with type 2 diabetes mellitus. The main question this study seeks to answer is: What is the effect of consuming 15 ml of organic apple cider vinegar every 12 hours for a period of 2 we...הצג עוד
תיאור מפורט
- Background and Rationale Type 2 diabetes mellitus (T2DM) represents a significant public health challenge worldwide, characterized by hyperglycemia resulting from insulin resistance and relative insulin secretion deficiency. The management of T2DM focuses on glycemic control to prevent micro- and macrovascular complications. While glycosylated hemoglobin (HbA1c) is a standard measure of long-term glycemic control,...
כותרת רשמית
Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus
מצבים רפואיים
Type 2 Diabetes Mellitus 2פרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:- Khezri SS, Saidpour A, Hosseinzadeh N, Amiri Z. Beneficial effects of Apple Cider Vinegar on weight management, Visceral Adiposity Index and lipid profile in overweight or obese subjects receiving restricted calorie diet: A randomized clinical trial. Journal of Functional Foods. 2018 Apr;43:95-102.
מזהי מחקר נוספים
- Apple vinegar
- 4706
מספר NCT
תחילת המחקר (בפועל)
2024-05-06
עדכון אחרון שפורסם
2026-03-25
סיום המחקר (מוערך)
2026-12
משתתפים (מתוכנן)
38
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
פעיל, לא מגייס
מילות מפתח
type 2 diabetes
apple cider vinegar
glycemic variability
CGM
satiety
apple cider vinegar
glycemic variability
CGM
satiety
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
מחקר מוצלב
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיApple cider vinegar 15 ml of apple cider vinegar diluted in 250 ml of water per mouth twice daily | Apple Cider Vinegar 15 ml of apple cider vinegar twice daily |
משווה פעילWater 250 ml of natural water per mouth twice daily | Apple Cider Vinegar 15 ml of apple cider vinegar twice daily |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Short-term glycemic variability (%) | Short-term glycemic variability, assessed with coefficient of variation (%). It will be measured for 14 days using a continuous glucose monitor. | 14 days |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Triglycerides (mg/dl) | The effect of consuming 15 ml of organic apple cider vinegar every 12 hours for two weeks on triglyceride concentration (mg/dl) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus | 14 days |
Weight (kg) | The effect of consuming 15 ml of organic apple cider vinegar every 12 hours for two weeks on weight (kg) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus | 14 days |
Postprandial glucose (mg/dl/h) | The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial glucose area under the curve (mg/dl/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
Postprandial insulin (mcg U/ml/h) | The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial area under the curve (mcg U/ml/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
Postprandial triglycerides (mg/dl/h) | The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial triglyceride area under the curve (mg/dl/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
Postprandial GLP-1 (pmol/l) | The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial GLP-1 (pmol) concentrations will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0 and 60 minutes during the mixed-meal tolerance test. |
Body fat (%) | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on body fat (%) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | 14 days |
Visceral fat (L) | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on visceral fat (L) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | 14 days |
Hunger | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on hunger, assessed using a visual analog scale for hunger and satiety, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test. |
Satiety | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on satiety, assessed using a visual analog scale for hunger and satiety, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test. |
Nausea | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on nausea, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Assessed after two weeks of intervention. |
Vomiting | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on vomiting, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Assessed after two weeks of intervention. |
Abdominal pain | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on abdominal pain, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Assessed after two weeks of intervention. |
Appetite | The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on decreased appetite, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus. | Assessed after two weeks of intervention. |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- Men and women
- Diagnosis of type 2 diabetes mellitus
- Age between 18 and 60 years
- Glycated hemoglobin (HbA1c) ≤ 8%
- Participant's ability to attend medical appointments, answer questionnaires, and undergo laboratory tests.
- Participant's ability to wear a Freestyle® device.
- Participant's acceptance and signature of informed consent.
- Acceptance of the intervention (consumption of 30 ml of apple cider vinegar) and avoidance of vinegar-based dressings for the entire duration of the intervention.
- Consent to participate in the study.
- Other types of diabetes
- Chronic kidney disease (eGFR < 60 ml/min)
- Allergy to apple cider vinegar
- Use of systemic steroids at supraphysiological doses
- Gastroesophageal reflux disease
- Peptic ulcer disease
- Documented gastroparesis
- Pregnancy or lactation
- Use of rapid-acting prandial insulin or analogs
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiranהגורם האחראי למחקר
Paloma Almeda-Valdés, חוקר ראשי, Staff Physician, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, 14080, Mexico