Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
NCT ID: NCT06042517
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
77 participants
INTERVENTIONAL
2023-09-30
2027-09-30
Brief Summary
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Detailed Description
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On day three subjects first undergo a third ultrasound session and then will either undergo Oral Glucose Tolerance Test (OGTT) with carbon13 (13C-glucose) tracer administration and subsequent NMR spectroscopy OR if enrolled into the HEC study arm will undergo euglycemic clamp testing. Following these procedures there will be an approximately two-week follow-up observational Period (with CGM). A two-week washout period will be followed by another cycle of the same procedures of either OGTT/NMR or HEC study, respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
5 additional subjects will be recruited to participate in cohort 3.
OTHER
SINGLE
Study Groups
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Cohort 1: Ultrasound during a hyperinsulinemic euglycemic clamp (HEC).
Hepatic ultrasound during a hyperinsulinemic euglycemic clamp (HEC).
Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
HEC - Hyperinsulinemic-Euglycemic-Clamp
A constant i.v. insulin and variable glucose infusion will be used to determine insulin sensitivity of study participants.
Cohort 2: Ultrasound then NMR with unlabeled glucose.
Hepatic ultrasound and subsequent NMR measurement of glycogen with unlabeled glucose.
Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
OGTT with unlabeled glucose and liver NMR
Subjects will undergo an OGTT with unlabeled glucose to measure liver glycogen concentration by NMR spectroscopy.
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
Cohort 3: Ultrasound then NMR with carbon13 labeled glucose.
Hepatic ultrasound and subsequent NMR measurement of glycogen with carbon13 labeled glucose.
Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
OGTT with carbon-13 labeled glucose and liver NMR
Subjects will undergo an OGTT with carbon-13 labeled glucose to measure liver glycogen synthesis rate by NMR spectroscopy.
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
Cohort 4: Dual site ultrasound stimulation followed by CGM glucose recording alone.
Hepatoportal plexus + superior mesenteric plexus dual site ultrasound stimulation followed by CGM glucose recording alone.
Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
Interventions
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Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
OGTT with unlabeled glucose and liver NMR
Subjects will undergo an OGTT with unlabeled glucose to measure liver glycogen concentration by NMR spectroscopy.
OGTT with carbon-13 labeled glucose and liver NMR
Subjects will undergo an OGTT with carbon-13 labeled glucose to measure liver glycogen synthesis rate by NMR spectroscopy.
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
HEC - Hyperinsulinemic-Euglycemic-Clamp
A constant i.v. insulin and variable glucose infusion will be used to determine insulin sensitivity of study participants.
Eligibility Criteria
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Inclusion Criteria
* All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor agonists.
* Subjects must demonstrate:
1. 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.
2. Be willing to carry a continuous glucose monitor for at least 10 days.
3. Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Raimund Herzog, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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2000034954
Identifier Type: -
Identifier Source: org_study_id
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