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New treatment option for Insulin Sensitivity
Official title Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
ClinicalTrials.gov ID: NCT06042517
What this study is testing
- What it's testing
- This study aims to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Type 2 diabetic (T2D) people must be aged 18-80 and must be able to provide written informed consent
- All people must have had T2D for at least 3 months prior to study enrollment. All people must be either on diet and exercise or oral antidiabetic...
- people must demonstrate:
- A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:
- A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
You likely can't join if
- BMI \>40kg/m2.
- Untreated proliferative retinopathy
- Creatinine clearance \< 60 ml/min/1.73 m2.
- Serum creatinine ≥1.5 mg/dL
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Active infection including hepatitis C, hepatitis B, HIV,
See the full eligibility criteria
- Type 2 diabetic (T2D) people must be aged 18-80 and must be able to provide written informed consent
- All people must have had T2D for at least 3 months prior to study enrollment. All people must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor...
- people must demonstrate:
- A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:
- A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
- A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or
- A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis or
- A hemoglobin A1c (HbA1c) level of 6.5% or higher.
- Be willing to carry a continuous glucose monitor for at least 10 days.
- Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
- BMI \>40kg/m2.
- Untreated proliferative retinopathy
- Creatinine clearance \< 60 ml/min/1.73 m2.
- Serum creatinine ≥1.5 mg/dL
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Active infection including hepatitis C, hepatitis B, HIV,
- Any history of Active alcohol abuse
- History of non-adherence to prescribed regimens
- Baseline Hgb \< 10.5 g/dL in females, or \< 13 g/dL in males
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- Co-existing cardiac disease with active medication titration. Patients on stable meds without active cardiac complications permitted.
- Liver function tests outside of 3xUL of normal range
- GI disorders potentially interfering with the ability to absorb oral medications and h/o upper GI surgery that might have changed anatomy in the target areas.
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.