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Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

ConditionInsulin Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYale University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent

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.

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

Disqualifiers

BMI >40kg/m2.

Untreated proliferative retinopathy

Creatinine clearance < 60 ml/min/1.73 m2.

Serum creatinine ≥1.5 mg/dL

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound

    Device

    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

    Diagnostic test

    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

    Diagnostic test

    Subjects will undergo an OGTT with carbon-13 labeled glucose to measure liver glycogen synthesis rate by NMR spectroscopy.

  • CGM glucose reading

    Diagnostic test

    A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.

  • HEC - Hyperinsulinemic-Euglycemic-Clamp

    Diagnostic test

    A constant i.v. insulin and variable glucose infusion will be used to determine insulin sensitivity of study participants.

Treatment groups

77 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Ultrasound during a hyperinsulinemic euglycemic clamp (HEC).Experimental treatment 3 interventions
Group B: Cohort 2: Ultrasound then NMR with unlabeled glucose.Experimental treatment 3 interventions
Group C: Cohort 3: Ultrasound then NMR with carbon13 labeled glucose.Experimental treatment 3 interventions
Group D: Cohort 4: Dual site ultrasound stimulation followed by CGM glucose recording alone.Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Insulin Sensitivity

Insulin Sensitivity calculated as Glucose disposal rate / insulin ratio during steady state (M/I) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)

Time frame
Measured during HE clamp.
2

Glucose disposal rate

Glucose disposal rate during steady state (M) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)

Time frame
Measured during HE clamp.
3

Glucose metabolic clearance rate

Glucose metabolic clearance rate during steady state (MCR) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)

Time frame
Measured during HE clamp.

Secondary outcomes

1

Absolute glycogen level

The effect of hepatic plexus-directed pFUS on absolute glycogen level by observing the metabolic fate of unlabeled glucose ingested during oral glucose tolerance testing measured by 13C liver NMR-spectroscopy.

Time frame
during glucose tolerance testing (for 180 minutes).
2

Glycogen synthesis rates

Glycogen synthesis rates are derived from plasma 13C -glucose levels achieved during the OGTT and subsequent appearance of 13C -tracer in liver glycogen

Time frame
during glucose tolerance testing (for 180 minutes).
3

Change from baseline in blood glucose (BG) time spent in defined glucose ranges

Change from baseline in blood glucose (BG) time spent in defined glucose ranges assessed using a continuous glucose monitoring system (CGMS)

Time frame
1 week
4

Average daily glucose

Average daily glucose assessed using a continuous glucose monitoring system (CGMS)

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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