- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07736040
The Impact of Diabetes Remission on Aging
The Ameliorative Role of Diabetes Remission in Aging: A Real-World-Based Prospective Clinical Cohort Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Pengfei Shan
- Telefonnummer: 86-0571-87783777
- E-post: pengfeishan@zju.edu.cn
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age 35 to 70 years.
- Diagnosis of type 2 diabetes mellitus according to WHO criteria, with disease duration ≤6 years.
- HbA1c between 7.0% and 9.5%, OR currently on glucose-lowering medications.
- Fasting C-peptide ≥1.0 ng/mL.
- Fasting plasma glucose <13.3 mmol/L.
- BMI between 25 and 45 kg/m².
- Willing and able to provide informed consent and comply with study procedures
Exclusion Criteria:
- Diabetes mellitus secondary to other causes (e.g., Cushing's syndrome, hypothyroidism, glucagonoma, drug-induced, or genetic factors).
- BMI <25 kg/m² or >45 kg/m²; weight loss >5% within the last 3 months; actively trying to lose weight within the last 3 months; use of weight-loss agents, contraceptives, glucocorticoids, or any medication other than antidiabetic drugs that may affect study outcome measurements within the last 3 months; history of bariatric surgery.
- Type 1 diabetes; type 2 diabetes duration >10 years; gestational diabetes; other specific types of diabetes.
- Diagnosis of acute metabolic diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) or diabetes insipidus within 30 days, or history thereof.
- Blood pressure ≥180/110 mmHg or malignant hypertension.
- History of severe gastrointestinal disease; significant cardiac, hepatic, renal, or other systemic organ dysfunction (NYHA functional class ≥II; ALT and/or AST >4× upper limit of normal; GFR <60 mL/min); anemia or other hematological disorders; history of malignancy.
- History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within the past 2 years.
Use within 3 months prior to screening of any of the following:
i. GLP-1 receptor agonists, GLP-1R/GCGR agonists, GIPR/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists; ii. Medications affecting body weight, including systemic corticosteroids (intravenous, oral, or intra-articular), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproate derivatives, lithium); iii. Chinese herbal medicines, dietary supplements, or meal replacements that affect body weight; iv. Previous or current use of anti-obesity drugs such as sibutramine, orlistat, phentermine, phenylpropanolamine, mazindol, diethylpropion, lorcaserin, phentermine/topiramate, naltrexone/bupropion; consumption of any alcoholic product within 48 hours prior to screening, or a positive alcohol screening test.
- Drug abuse or alcohol dependence; severe psychiatric or neurological disorders.
- Pregnant or breastfeeding women, or women planning to become pregnant within 1 year.
- Special dietary requirements, or allergy to soy, dairy, or other foods.
- Current participation in another clinical trial; unwillingness to comply with the lifestyle management and follow-up of this study; or judged by the investigator to be unsuitable for participation.
- Unwilling or unable to provide informed consent.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Comprehensive Lifestyle Intervention
|
Participants will receive a 24-week comprehensive lifestyle intervention:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
Tidsram: Baseline to 24 weeks
|
DunedinPACE is derived from Illumina Epic DNA methylation data.
The change score is compared between participants with and without diabetes remission (remission defined as HbA1c <6.5% off glucose-lowering drugs for ≥3 months).
|
Baseline to 24 weeks
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Pengfei Shan, Second Affiliated Hospital, School of Medicine, Zhejiang University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-0812
Plan för individuella deltagardata (IPD)
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