Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation

Официальное название

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.

Обзор

Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes. The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.

Вмешательства

• Другое hyperinsulinemic-hypoglycemic clamp
  An intravenous catheter will be placed in an antecubital vein for infusion of insulin and glucose. A second catheter will be placed retrograde in a dorsal vein of the contra-lateral hand for blood withdrawal. The hand will be placed in a heating box or pad at 70°C for arterialization of venous blood. A primed infusion of regular insulin (120 mU/min/m2) will be initiated and continued for approximately 2 hours. Beginning 20 minutes prior to the start of the insulin infusion, arterialized venous b
• Другое 13C-MRS procedure/Acetate infusion
  Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples

Первичные конечные точки

• Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS) [Срок оценки: Every ten minutes for 120 minutes following administration of 1-13C acetate]

Вторичные конечные точки (1)

• Change in serum epinephrine levels [Срок оценки: epinephrine will be measured every 15 minutes for 135 minutes.]

Критерии участия

Критерии включения

• Healthy male or female
• Ages 18-40 years
• BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
• Medically cleared for participation in the study

Критерии исключения

• Contraindication to MRI
• Consume >10 alcoholic drinks/week
• History of chronic smoking or have quit less than 10 years ago
• History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
• Average screening blood pressure >140/90 mmHg
• History of cardiovascular disease
• Pregnant, planning to become pregnant, or breastfeeding
• Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
• Use of beta-adrenergic antagonists.
• Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Pennington Biomedical Research Center — Baton Rouge

Идентификаторы

NCT: NCT04207619 · PBRC 2019-047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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