저혈당증 관련 자율신경 부전의 기전

실험적: Healthy

Healthy individuals will receive drug (naloxone, morphine sulfate, epinephrine) and placebo comparator.

의약품: 날록손

1일차에 날록손을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 나르칸

건강 보조 식품: 과당

1일차에 과당을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 인슐린

행동: 운동

1일차에 운동을 관리하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

의약품: 모르핀 설페이트

1일차에 모르핀을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 모르핀

의약품: 에피네프린

1일차에 에피네프린을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 아드레날린

실험적: Type 1 Diabetes

T1D individuals will receive drug (naloxone, morphine sulfate, epinephrine) and placebo comparator.

의약품: 날록손

1일차에 날록손을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 나르칸

건강 보조 식품: 과당

1일차에 과당을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 인슐린

행동: 운동

1일차에 운동을 관리하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

의약품: 모르핀 설페이트

1일차에 모르핀을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 모르핀

의약품: 에피네프린

1일차에 에피네프린을 투여하고 2일차에 저혈당증에 대한 역조절 반응을 정량화합니다.

다른 이름들:

• 아드레날린

Endogenous Glucose Production (EGP) Response Rate - Morphine Sulfate Study

EGP response after antecedent morphine administration was assessed in the Morphine Sulfate vs Matched Placebo study. EGP response is a measure of how the body produces glucose from substrates to maintain blood sugar levels, particularly during fasting. Morphine was administered on Day 1 followed by a stepped hypoglycemia clamp (i.e., euglycemia → 90 mg/dl → 80 mg/dl → 70 mg/dl → 60 mg/dl) on Day 2. EGP response rate is reported in milligrams/kilograms/minute (mg/kg/min) and results are summarized and reported by study arm using basic descriptive statistics. Data from the final hour of the 3rd clamp episode were averaged/reported.

Endogenous Glucose Production (EGP) Via Glucose Infusion Rate - Naloxone Study

For the Naloxone vs Matched Placebo study, EGP, a measure of the body's production of sugar, was assessed by determining the Glucose Infusion Rate (GIR) an indirect measure of endogenous glucose production, during the first and third hypoglycemic clamp episodes. GIR is reported in cubic centimeters/minute (cc/min) and results are summarized and reported by study arm using basic descriptive statistics.

Endogenous Glucose Production (EGP) Response Rate - Epinephrine Study

EGP response after antecedent epinephrine administration was assessed in the Epinephrine vs Matched Epinephrine study. EGP response, a measure of how the body produces glucose from substrates to maintain blood sugar levels, was assessed during the final hypoglycemic clamp episode. EGP at the major nadir at the 60 mg/dL, during the last 10 minutes of the 3rd clamp episode, is reported in milligrams per kilogram per minute (mg/kg/min) and results are summarized and reported by study arm using basic descriptive statistics. Data from the final hour of the 3rd clamp episode were averaged/reported

Counterregulatory Response to Hypoglycemia - Morphine Sulfate Study

Counterregulatory response to hypoglycemia was assessed for the Morphine Sulfate study by quantifying peak plasma responses to three episodes of induced hypoglycemia over two days: two, 2-hour episodes of moderate hyper-insulinemic, hypoglycemic clamp studies (target glucose 54 mg/dL), separated by a 2-hour break with a small snack, on Day 1, followed by a third, comparable hypoglycemic episode on Day 2. Group mean results are summarized for the Morphine Sulfate arm and Matched Placebo arm.

Counterregulatory Response to Hypoglycemia - Naloxone Study

Counterregulatory response to hypoglycemia was assessed for the Naloxone study by quantifying peak plasma responses to three episodes of induced hypoglycemia over two days: two, 2-hour episodes of moderate hyper-insulinemic, hypoglycemic clamp studies (target glucose 54 mg/dL), separated by a 2-hour break with a small snack, on Day 1, followed by a third, comparable hypoglycemic episode on Day 2. The second challenge on Day 1 was conducted to assess the impact of the third episode for informational purposes only but was not reported. Group mean results are summarized for the 1st and 3rd episodes in the Naloxone arm and Matched Placebo arm.

Counterregulatory Response to Hypoglycemia - Epinephrine Study

Counterregulatory response to hypoglycemia was assessed for the Epinephrine study by quantifying peak plasma epinephrine level responses to three episodes of induced hypoglycemia over two days: two, 2-hour episodes of moderate hyper-insulinemic, hypoglycemic clamp studies (target glucose 60 mg/dL), separated by a 2-hour break with a small snack, on Day 1, followed by a third, comparable hypoglycemic episode on Day 2. Group mean results are summarized for the Epinephrine arm and Matched Placebo arm.

Hypoglycemic Symptom Scores - Morphine Sulfate Study

Hypoglycemic Symptom Scores were evaluated using the Edinburgh Hypoglycemia Symptom Scale (EHSS). The EHSS is an instrument to evaluate patients' experiences of symptoms in a typical hypoglycemic episode. It is comprised of 11 symptoms within 3 domains: Neuroglycopenic (i.e., confusion, drowsiness, odd behavior, speech difficulty, and incoordination), Autonomic (i.e., sweating, palpitations, shaking, and hunger), and General Malaise (i.e., headaches, nausea); which are evaluated by a 8-point Likert scale ranging from 0 = "Not at all" to 7 = "Very severely." An overall global mean composite score for the 11 symptoms was summed and averaged for each participant during the 3rd hypoglycemic episode on Day 2. Higher scores are indicative of more EHSS symptoms. Group mean values will be reported using basic descriptive statistics.

Hypoglycemic Symptom Scores - Naloxone Study

Hypoglycemic Symptom Scores were evaluated using the Edinburgh Hypoglycemia Symptom Scale (EHSS). The EHSS is an instrument to evaluate patients' experiences of symptoms in a typical hypoglycemic episode. It is comprised of 11 symptoms within 3 domains: Neuroglycopenic (i.e., confusion, drowsiness, odd behavior, speech difficulty, and incoordination), Autonomic (i.e., sweating, palpitations, shaking, and hunger), and General Malaise (i.e., headaches, nausea); which are evaluated by a 8-point Likert scale ranging from 0 = "Not at all", to 7 = "Very severely." An overall global mean composite score for the 11 symptoms was summed and averaged for each participant during the 3rd hypoglycemic episode on Day 2. Higher scores are indicative of more EHSS symptoms. Group mean values will be reported using basic descriptive statistics.

Hypoglycemic Symptom Scores - Epinephrine Study

Hypoglycemic Symptom Scores were evaluated using the Edinburgh Hypoglycemia Symptom Scale (EHSS). The EHSS is an instrument to evaluate patients' experiences of symptoms in a typical hypoglycemic episode. It is comprised of 11 symptoms within 3 domains: Neuroglycopenic (i.e., confusion, drowsiness, odd behavior, speech difficulty, and incoordination), Autonomic (i.e., sweating, palpitations, shaking, and hunger), and General Malaise (i.e., headaches, nausea); which are evaluated by a 7-point Likert scale ranging from 1 = "Not at all", to 7 = "Very severely." An overall global mean composite score for the 11 symptoms was summed and averaged for each participant during the 3rd hypoglycemic episode on Day 2. Higher scores are indicative of more EHSS symptoms. Group mean values will be reported using basic descriptive statistics.

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