Type 2 Diabetes Mellitus
Conditions
Brief summary
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
Detailed description
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might improve glucose metabolism and insulin sensitivity. Some clinical studies have shown that glucose metabolism is improved in patients with resistant hypertension both 1 and 3 months after denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
Interventions
DEVICEEndovascular Denervation
multi-electrode catheter-based endovascular denervation
Sponsors
Zhongda Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Over 18 years and ≤ 70 years old * Able and willing to provide informed consent * Patients with established type II diabetes mellitus (HbA1C\>7.5%, diet or oral hypoglycaemic agents) * Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days. * Anticipated that patients are able to maintain a stable dose of medication for the duration of the study
Exclusion criteria
* Arterial anatomy ineligible for endovascular denervation * History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation * Type 1 diabetes mellitus * Pregnant, nursing or planning to be pregnant * Orthostatic hypotension * eGFR \<30 ml/min (MDRD formula) * Patients that have allergy to contrast agent * Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion * Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion * Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Oral Glucose Tolerance Test from baseline to 6 months | 6 months | To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT). |
| Changes in glycosylated hemoglobin from baseline to 6 months | 6 months | To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Oral Glucose Tolerance Test up to 2 years | 3, 12 and 24 months | To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT). |
| Changes in glycosylated hemoglobin up to 2 years | 3, 12 and 24 months | To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c). |
| Changes in insulin up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on insulin. |
| Changes in catecholamine up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on catecholamine. |
| Changes in glucagon up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on glucagon. |
| Changes in blood pressure up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on blood pressure. |
| Changes in creatinine up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on creatinine. |
| Changes in blood urea nitrogen (BUN) up to 2 years | 3, 6, 12 and 24 months | To investigate the influence of endovascular denervation on BUN. |
Countries
China
Contacts
Primary ContactGao-Jun Teng,, MD
Backup ContactTao Pan, PhD
Outcome results
None listed