The Impact of Diabetes Remission on Aging

July 26, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective real-world cohort study will enroll 100 Chinese patients with type 2 diabetes, aged 35-70 years. All participants will receive a 24-week multimodal intervention comprising caloric restriction, dietary counseling, exercise training, and adjustment of glucose-lowering medications. DNA methylation levels will be assessed using the Illumina Epic array to calculate the epigenetic aging clock (DunedinPACE), enabling evaluation of changes in biological aging from baseline to 24 weeks, as well as comparisons between patients with and without successful remission. In addition, changes in inflammatory cytokines, metabolic parameters, body composition, and other aging-related biomarkers will be monitored. The findings are expected to provide novel evidence for the benefits of type 2 diabetes remission.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive Lifestyle Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Pengfei Shan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 9, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 26, 2026

First Submitted That Met QC Criteria

July 26, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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