The Impact of Diabetes Remission on Aging

Korábbi kezelés

• Use within 3 months prior to screening of any of the following:
  • 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.

Más betegség

• 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.
• 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 bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within the past 2 years.
• Drug abuse or alcohol dependence; severe psychiatric or neurological disorders.
• Special dietary requirements, or allergy to soy, dairy, or other foods.

Laborértékek

• 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.

Életkor

• Type 1 diabetes; type 2 diabetes duration >10 years; gestational diabetes; other specific types of diabetes.

Egyéb

• Pregnant or breastfeeding women, or women planning to become pregnant within 1 year.
• 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.

• 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