The Impact of Diabetes Remission on Aging

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Comprehensive Lifestyle Intervention

    Other 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Comprehensive Lifestyle InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in DunedinPACE epigenetic clock from 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).

Time frame
Baseline to 24 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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