- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07736040
The Impact of Diabetes Remission on Aging
The Ameliorative Role of Diabetes Remission in Aging: A Real-World-Based Prospective Clinical Cohort Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Pengfei Shan
- Telefonnummer: 86-0571-87783777
- E-mail: pengfeishan@zju.edu.cn
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Comprehensive Lifestyle Intervention
|
Participants will receive a 24-week comprehensive lifestyle intervention:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Pengfei Shan, Second Affiliated Hospital, School of Medicine, Zhejiang University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-0812
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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