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NCT07736040

The Impact of Diabetes Remission on Aging

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

This study is a real-world, prospective clinical cohort study. It will enroll Chinese patients with type 2 diabetes. The aim is to assess the changes in aging biomarkers, primarily DunedinPACE, from baseline to post-remission, and to compare these biomarkers between patients who achieve successful remission and those who do not.

Official title: The Ameliorative Role of Diabetes Remission in Aging: A Real-World-Based Prospective Clinical Cohort Study

Key Details

Gender

All

Age Range

35 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-07-09

Completion Date

2027-06-30

Last Updated

2026-07-30

Healthy Volunteers

Yes

Conditions

Type 2 Diabetes

Interventions

OTHER

Comprehensive Lifestyle Intervention

Participants will receive a 24-week comprehensive lifestyle intervention： 1. Individualized calorie-restricted low-carbohydrate diet: 800-1000 kcal/day if body weight \<80 kg, or 1000-1200 kcal/day if ≥80 kg; each meal includes \~200 g vegetables and \~100 g lean protein, with low fat/sugar/salt; avoid high-fat meats and organ foods; daily food weighing and recording required. 2. Aerobic exercise ≥150 min/week at moderate intensity (50-70% of maximal heart rate) plus 2-3 resistance training sessions weekly. 3. Monthly nutrition clinic visits for dietary adjustment. 4. Self-monitoring of weight and fasting glucose ≥2 times/week; monthly in-person follow-ups for the first 6 months. 5. Hypoglycemic agents: baseline doses maintained; if fasting glucose \<7 mmol/L and 2-h postprandial glucose \<10 mmol/L, reduce 1-2 drug types per step; hypoglycemia episodes managed by investigator for dose reduction or discontinuation.

Inclusion Criteria: 1. Age 35 to 70 years. 2. Diagnosis of type 2 diabetes mellitus according to WHO criteria, with disease duration ≤6 years. 3. HbA1c between 7.0% and 9.5%, OR currently on glucose-lowering medications. 4. Fasting C-peptide ≥1.0 ng/mL. 5. Fasting plasma glucose \<13.3 mmol/L. 6. BMI between 25 and 45 kg/m². 7. Willing and able to provide informed consent and comply with study procedures Exclusion Criteria: 1. Diabetes mellitus secondary to other causes (e.g., Cushing's syndrome, hypothyroidism, glucagonoma, drug-induced, or genetic factors). 2. 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. 3. Type 1 diabetes; type 2 diabetes duration \>10 years; gestational diabetes; other specific types of diabetes. 4. Diagnosis of acute metabolic diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) or diabetes insipidus within 30 days, or history thereof. 5. Blood pressure ≥180/110 mmHg or malignant hypertension. 6. 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. 7. History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within the past 2 years. 8. 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. 9. Drug abuse or alcohol dependence; severe psychiatric or neurological disorders. 10. Pregnant or breastfeeding women, or women planning to become pregnant within 1 year. 11. Special dietary requirements, or allergy to soy, dairy, or other foods. 12. 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. 13. Unwilling or unable to provide informed consent.