NCT07423065Felfüggesztve
The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity
The Impact of Continuous Glucose Monitoring on Behavioral Change, Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity - a Randomized Crossover Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.
Megadott ok: The study has been temporarily suspended pending approval from the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP). The need for this additional regulatory approval was identified following communication with JAZMP.
Rövid összefoglaló (regiszter, angolul)
This randomized, crossover interventional study evaluates the effects of real-time (open) versus blinded continuous glucose monitoring (CGM) on glycemic variability, lifestyle behaviors, and metabolic outcomes in adults with prediabetes and overweight or obesity (BMI ≥ 27 kg/m²). Thirty participants will undergo both open and blinded CGM phases, separated by a washout period. The study aims to assess whether access to real-time glucose data promotes behavioral change and improves metabolic health compared with blinded CGM use.
- Állapot (regiszter)
- Felfüggesztve
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 34 (tervezett)
- Első benyújtás
- 2026. jan. 26.
- Kezdés
- 2026. dec. 15.
- Elsődleges befejezés
- 2027. dec. 1.
- Fő szponzor
- University of Primorska
- Betegségek
- Elhízás
- NCT-szám
- NCT07423065
Ki nem vehet részt
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Korábbi kezelés
- Any antidiabetic medication (insulin, metformin, GLP-1RA, SGLT2i, etc.), or anti-obesity pharmacotherapy.
- Participation in another interventional study within the previous 3 months.
Más betegség
- Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome).
- Severe psychiatric illness or cognitive impairment limiting adherence or comprehension.
- Known allergy or skin reaction to CGM adhesives or device materials.
Laborértékek
- Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%).
- Severe chronic disease that could influence glucose metabolism or study participation (e.g., chronic liver disease, renal failure, active malignancy).
- Use of medications known to affect glucose metabolism (e.g., corticosteroids, atypical antipsychotics).
Egyéb
- Current or recent (within 3 months) use of:
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Implanted electronic medical devices (e.g., pacemaker, defibrillator) that may interfere with CGM function.
Kiket keres a vizsgálat
- Adults aged 18-70 years.
- BMI ≥ 27 kg/m² (overweight or obese).
- Prediabetes, confirmed by:
- Impaired fasting glucose (IFG: 5.6-6.9 mmol/L), and/or Impaired glucose tolerance (IGT: 2-hour OGTT glucose 7.8-11.0 mmol/L).
- Stable body weight (±3 kg) in the last 3 months.
- No current use of antidiabetic or weight-loss medications.
- Willingness and ability to wear a CGM device as instructed.
- Capacity to provide written informed consent.
- Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper (identified and invited from the clinic's database).
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Primorska, Faculty of Health Sciences | Izola | Szlovénia | Ismeretlen állapot |
| Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia | Koper | Szlovénia | Ismeretlen állapot |
| Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana | Ljubljana | Szlovénia | Ismeretlen állapot |
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