A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control

NCT07678866 | Recruiting DMC

• 1 other identifier: ZLYL202601
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

experiment design: Single-center, single-arm, open-label trial Inclusion Criteria:

1. 1.Ages 18-70.
2. 2.At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
3. 3.The glycated hemoglobin level is 7.5%-10.5%.
4. 4.BMI 2 7-40 kg/m2.
5. 5.Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
6. 6.Stable body weight (defined as a weight change of \<5% within 5 weeks prior to screening)
7. 7.Donation of blood is prohibited during the trial participation period.
8. 8.The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
9. 9.Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
10. 10.Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

pulsed electric field ablation system; Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment

  Observation period: 6 months postoperatively.

Secondary Outcomes (4)

• HbA1c: The difference in HbA1c levels from the baseline period to after treatment

  Observation periods: 1 month, 3 months, and 12 months post-treatment.

• Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment

  Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.

• Weight: Average weight from the baseline period to post-treatment

  Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.

• Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.

  Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment.

Study Arms (1)

The pulsed electric field ablation system in treating adult type 2 diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Ages 18-70. 2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus. 3. The glycated hemoglobin level is 7.5%-10.5%. 4. BMI 2 7-40 kg/m2. 5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.

You may qualify if:

• Ages 18-70.
• At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
• The glycated hemoglobin level is 7.5%-10.5%.
• BMI 2 7-40 kg/m2.
• Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
• Stable body weight (defined as a weight change of \<5% within 5 weeks prior to screening)
• Donation of blood is prohibited during the trial participation period.
• The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
• Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
• Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.

You may not qualify if:

• Diagnosed with type 1 diabetes mellitus.
• Severe diabetes-related complications such as diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Fasting serum C-peptide \<1 ng/mL (333 pmol/L).
• Over the past two years, insulin of any type has been used for more than 1 month (excluding treatment for gestational diabetes mellitus).
• History of ≥1 severe hypoglycemic episode within the past 6 months (defined as requiring assistance from a third party).
• Currently using a GLP-1RA or a dual GLP-6/GIP agonist.
• Known autoimmune diseases.
• Previous gastrointestinal surgery that has altered the anatomical structure of the digestive tract or may limit duodenal resection, such as Billroth II, Roux-en-Y gastric bypass, gastric banding, or other similar procedures/diseases.
• A known history of upper gastrointestinal structural or functional disorders may impede device passage through the upper gastrointestinal tract or increase the risk of tissue injury during endoscopic procedures, including upper gastrointestinal strictures, esophageal-gastric varices, large diverticula, or other severe esophageal, gastric, or duodenal pathologies.
• History of gastroparesis.
• Acute gastrointestinal disease has occurred within the past 7 days.
• A history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel diseases such as Crohns disease and celiac disease is known.
• Previous history of chronic or acute pancreatitis.
• Active hepatitis or active liver disease, or an alanine aminotransferase (ALT) level\>3.0 times the upper limit of normal (ULN) as determined by the central laboratory during screening evaluation.
• Currently, vitamin K antagonists such as warfarin are being used, or oral anticoagulants (DOCA) that cannot be safely discontinued are being administered.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lan Zhong

CONTACT

86-131620099450; lanzhong@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-05

Locations

CN (1)