RECRUITING

Regulation of Endogenous Glucose Production by Central KATP Channels

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Conditions

Type 2 Diabetes MellitusGlucose Metabolism DisordersGlucose, High Bloodtype 2 diabetesdiabetesinsulin resistancediazoxide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.

Official Title

Regulation of Endogenous Glucose Production by Central KATP Channels

Quick Facts

Study Start:2018-08-01
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03540758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 21-70 years old
  2. * Body Mass Index (BMI) under 35
  3. * Negative drug screen
  4. * Normal Hemoglobin A1c (HbA1c) and fasting glucose
  5. * No family history of diabetes among first degree relatives (e.g., mother, father)
  6. * Age: 21-70 years old
  7. * BMI under 35
  8. * Stable and moderate-to-poor glycemic control (HbA1c: 8.0-12.0%)
  9. * Negative drug screen
  10. * Not suffering from a previously diagnosed proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction).
  1. * Age: Under 21 or over 70 years ol
  2. * BMI: \>35 for Type 2 Diabetes (T2D) and Non-Diabetic (ND) subjects
  3. * Blood pressure \>150/90 or \<90/60 on more than one occasion
  4. * Severe polydipsia and polyuria (in subjects with T2D). Since polydipsia and polyuria are common symptoms of T2D, the distinction "severe" denotes that the subject indicates a worsening in the symptoms and/or an experience of discomfort related to the symptoms at the time of screening and/or at the time of withdrawal from the medications
  5. * Urine microalbumin: \>300 mg/g of creatinine (in subjects with T2D)
  6. * Uncontrolled hyperlipidemia defined as Triglycerides (TG) \> 400 mg/dL and/or Total Cholesterol \>300 mg/dL
  7. * Clinically significant liver dysfunction including thrombocytopenia (platelets \<100,000/uL), anemia (as below), hypoalbuminemia (\<3.5 g/dL), coagulopathy (INR \> 1.5), and/or liver enzymes more than 3 times the upper limit of normal
  8. * Clinically significant kidney dysfunction, Glomerular Filtration Rate (GFR): \<60 mg/dL
  9. * Clinically significant anemia Prospective subjects with hemoglobin below the lower limit of 12 g/dl for for men and 11 g/dL for women will be assessed with history and physical exam to rule out clinically significant anemia, defined as an individual with symptoms (e.g., fatigue, weakness, shortness of breath, palpitations), signs (pallor, brittle nails etc.), or currently under treatment for anemia. In the absence of a documented hemoglobin decrease or iron deficiency, subjects will not be excluded
  10. * Clinically significant leukocytosis or leukopenia
  11. * Clinically significant thrombocytopenia or thrombocytosis
  12. * Coagulopathy
  13. * Urine drug screen positive for any of the following: amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone, phencyclidine (PCP). Amphetamines, oxycodone, opiates, methadone, and benzodiazepines have been shown to affect glucose metabolism (increased glycemia, increased fasting insulin levels, delayed insulin response to food ingestion, insulin deficiency). As the drug test available in the Clinical Research Center (CRC) is a 7-drug panel, we cannot specifically choose which drugs are screened for. Additionally, in the interest of selecting patients on the basis of their reliability and dependability, we would like to exclude participants using illicit drugs. Occasional use of cannabis (once or twice per week) is not an exclusion factor. If the test is read as "indeterminate" it will be repeated at the bedside and an additional sample will be sent to the lab. Decision to enroll subject that day prior to results from lab being available will be decided on a case-by-case basis, i.e., when all previous drug testing had been negative and clinical suspicion is very low
  14. * Urinalysis: Clinically significant abnormalities
  15. * Clinically significant electrolyte abnormalities
  16. * Smoking \>10 cigarettes/day
  17. * Alcohol: Men \>14 drinks/week or \>4 drinks/day, Women \>7 drinks/week or \>3 drinks/day
  18. * History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease
  19. * Surgeries that involve removal of endocrine glands except for thyroidectomy (if euthyroid on thyroid hormone replacement - if such history free thyroxine (fT4) and Thyroid Stimulating Hormone (TSH) will be checked)
  20. * Pregnant women
  21. * Subject enrolled in another study less than one month prior to the anticipated start date of the proposed study, besides those done by our group
  22. * Family history of premature cardiac death
  23. * Allergies to medication administered during study
  24. * Uncontrolled psychiatric disorders
  25. * Any condition which in the opinion of the PI makes the subject ill suited for participation in the study

Contacts and Locations

Study Contact

Meredith Hawkins, M.D., M.S.
CONTACT
718-430-2903
meredith.hawkins@einsteinmed.edu

Principal Investigator

Meredith Hawkins, M.D., M.S.
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine

Study Locations (Sites)

Albert Einstein College of Medicine
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Meredith Hawkins, M.D., M.S., PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-01
Study Completion Date2027-04

Study Record Updates

Study Start Date2018-08-01
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • type 2 diabetes
  • diabetes
  • insulin resistance
  • diazoxide

Additional Relevant MeSH Terms

  • Type 2 Diabetes Mellitus
  • Glucose Metabolism Disorders
  • Glucose, High Blood