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Идёт набор NCT03228732

The Effects of Fluoxetine and/or DHEA

Ранняя фаза I С лечением Type 1 Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Placebo Oral Tablet, Placebo Oral Tablet, Fluoxetine, DHEA.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes Mellitus. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

The Effects of the Selective Serotonin Reuptake Inhibitor, Fluoxetine and/or DHEA, on Neuroendocrine, Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals

Обзор

(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.

Вмешательства

  • Препарат Placebo Oral Tablet
    There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
  • Препарат Placebo Oral Tablet
    There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
  • Препарат Fluoxetine
    There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
  • Препарат DHEA
    There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
  • Препарат Fluoxetine and DHEA
    There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.

Первичные конечные точки

  • Change in the level of catecholamines in plasma [Срок оценки: An average of 3 years]

Критерии участия

Критерии включения

  • 64 (32 males, 32 females) T1DM patients aged 18-50 yr.
  • HbA1c < 11.0%
  • No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
  • Body mass index < 40kg · m-2

Критерии исключения

  • Pregnancy
  • Subjects unable to give voluntary informed consent
  • Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
  • Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
  • Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
  • Subjects that score greater than 50 on the depression scale
  • Subjects unwillingness or inability to comply with approved contraception measures
  • Abnormal results following screening tests and physical examination that are clinically significant
  • Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
  • Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
  • Pneumonia
  • Hepatic Failure/Jaundice
  • Creatinine greater than 1.6 mg/dl
  • Acute Cerebrovascular/ Neurological deficit
  • Fever greater than 38 °C

Screening Laboratory Tests Exclusion Criteria

  • Hematocrit lower than 32
  • WBC lower than 3 thou/ul or greater than 14 thou/ul
  • Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
  • TBil greater than 2 mg/dl
  • Alkaline Phosphatase greater than 150U/L
  • Positive HIV, Hep B, Hep C
  • Hepatic transaminase > 2x normal

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Maryland — Baltimore

Идентификаторы

NCT: NCT03228732 · HP-00075896

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗