Phase 1 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 21 to 65 years at the time of enrolling in the study
• People diagnosed with type 2 diabetes, with blood sugar levels within a specific range (fasting blood glucose between 140–270 mg/dL), a blood sugar control marker (HbA1c) between 7.0% and 9.0%, triglyceride (blood fat) levels below 400 mg/dL, who have had type 2 diabetes for 10 years or less, and who are currently taking metformin (with or without one other oral diabetes medication)
• People diagnosed with high blood pressure, with office blood pressure readings of systolic (top number) between 140–180 mmHg and diastolic (bottom number) at or above 90 mmHg, and a 24-hour monitored average systolic reading between 130–170 mmHg, currently managed with up to three oral blood pressure medications
• People with a body mass index (BMI) between 27.5 and 40 kg/m²
• People with a specific blood test result (C-peptide at or above 2 ng/mL) indicating the body is still producing some insulin
• People whose renal (kidney) or hepatic (liver) arteries meet specific size requirements — between 3 mm and 7 mm wide, with at least 20 mm of usable length — as assessed by the trial site

Who may not be able to join:

• People with type 1 diabetes, or type 2 diabetes that is poorly controlled (HbA1c above 9.0%, or currently using insulin to manage blood sugar)
• People whose diastolic (bottom number) blood pressure reading at the clinic is below 90 mmHg
• People currently taking more than three blood pressure medications
• People currently taking beta-blocker medications
• People who have been hospitalised due to high blood sugar episodes in the 180 days before screening
• People who have experienced unawareness of low blood sugar episodes, or serious low blood sugar causing loss of consciousness or confusion in the past 6 months
• People with a BMI above 40 kg/m²
• People diagnosed with advanced diabetic eye disease (proliferative retinopathy) or nerve damage in the hands or feet (peripheral neuropathy)
• People whose artery anatomy is not suitable for the procedure, as assessed by the treating doctor
• People who have previously had any procedure performed on their kidney or liver arteries (such as stenting or balloon angioplasty)
• People with a narrowing of more than 50% in any of the target arteries
• People with artery conditions such as aneurysm, excessive bending, or hardening that the doctor determines would make the procedure unsafe
• People with blocked blood vessels in the legs that would prevent the procedure from being performed through the groin
• People with a known or suspected secondary cause of high blood pressure, such as Cushing's disease, overactive adrenal glands, certain thyroid or parathyroid conditions, a history of pre-eclampsia, or high blood pressure that began before age 18
• People who regularly use anti-inflammatory pain medications (such as ibuprofen or naproxen) two or more days per week in the month before enrolling
• People with serious or unstable heart or lung conditions, including recent heart attack, heart failure (NYHA Class III or IV), chronic irregular heartbeat (atrial fibrillation), significant heart valve narrowing, blood clots in the lungs, or severe chronic lung disease
• People with a history of kidney transplant, removal of a kidney, a single kidney, kidney tumour, non-functioning kidney, significantly different kidney sizes linked to kidney disease, reduced kidney function (eGFR at or below 60 ml/min/1.73m²), or currently on dialysis
• People who have had a liver transplant
• People who are planning to have any organ transplant within 12 months after the main procedure
• People who have had permanent surgical changes to the digestive system
• People who have had any surgery in the 30 days before the main procedure
• People who have taken, or are expected to need, certain medications — including systemic corticosteroids, anti-seizure medications, or centrally acting sympatholytics — within 90 days before screening or during the study
• People with bleeding disorders, severely low platelet counts, or severe anaemia
• People on blood-thinning medications that cannot be safely stopped in the period around the procedure
• People with any other condition the trial doctor determines would affect safety or study quality
• People who drink more than 2 standard drinks per day (women) or 3 standard drinks per day (men), or who cannot reliably report their alcohol intake
• People with active substance abuse (including inhaled or injected drugs) within the past year, based on the investigator's assessment
• People who have lost more than 10% of their total body weight in the past 6 months
• People with signs of serious liver failure, including low albumin, abnormal clotting results, high bilirubin, or a history of certain liver complications such as oesophageal varices, fluid in the abdomen, or liver-related confusion
• People with significantly elevated liver enzyme levels (ALT or AST above 200 U/L)
• People diagnosed with liver cirrhosis
• People with a history of certain chronic liver or bile duct conditions, including Hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, alpha-1-antitrypsin deficiency, haemochromatosis, drug-induced liver disease, bile duct blockage, or liver cancer
• People with a history of acute or chronic pancreatitis (inflammation of the pancreas)
• People living with HIV
• People with a history of allergic reaction to heparin, or a condition called heparin-induced thrombocytopenia (HIT)
• People with a current serious infection that the investigator determines would make the procedure too risky
• People with known allergies to contrast dye, nickel, or ethanol that cannot be adequately managed with pre-treatment
• People who are currently depressed or taking antidepressant medications
• People who are pregnant, breastfeeding, or planning to become pregnant in the next 12 months
• People with a life expectancy of less than 5 years
• People who are unwilling or unable to attend the required follow-up visits
• People who are unable to provide informed consent themselves or through an authorised representative
• People with other medical conditions that the investigator determines could affect the assessment of results or compromise safety
• People currently participating in another clinical trial for an unapproved drug or medical device

Important: Always verify eligibility with the trial site directly before applying.