Status:
COMPLETED
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
Lead Sponsor:
University Health Network, Toronto
Conditions:
Insulin Resistance
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
It is well known that the hormone insulin lowers blood glucose in part by acting directly on the liver and reducing hepatic glucose production. Animal studies have shown that the hormone insulin can a...
Detailed Description
Each study participant will be admitted to hospital the evening prior to the study. Following admission each study participant will be provided with a standardized dinner. At 7am (t=0) the next day we...
Eligibility Criteria
Inclusion
- Men and women, aged 18 to 60 years
- Body mass index \>30 kg/m2
- Hemoglobin in the normal range.
- Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
- Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.
Exclusion
- Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
- Any current or previous history of endocrine disease, dyslipidemia or malignancy
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP \> 100 or systolic \> 180 or systolic BP\<100) or proliferative retinopathy
- Use of immunosuppressive agents at any time during the study
- Allergy to any study medication
- Pregnancy or breastfeeding
- Heavy smoker
- Prior nasoduodenal tube insertion under fluoroscopic guidance.
- Fasting blood glucose \> 6.0 mmol/l or known diabetes.
- Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure.
- Any nasal pathology likely to affect absorption of insulin or insertion of nasoduodenal tube.
- Any laboratory values: aspartate transaminase \> 2x upper limit of normal; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 micro unit/l
- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Taking any regular prescription or non-prescription medications at the time of the study. Occasional use of medications such as acetoaminophen or Tylenol 1 or any use of natural health products may be permitted at the discretion of the investigator.
- Will not donate blood three months prior to and three months post study procedures
Key Trial Info
Start Date :
September 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03383822
Start Date
September 8 2015
End Date
December 1 2017
Last Update
December 26 2017
Active Locations (1)
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1
Tornto General Hospital, UHN
Toronto, Ontario, Canada, M5G 1L7