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(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 1 | Placebo Comparator | Visit 1: Study Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1 |
|
| Placebo 2 | Placebo Comparator | Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo Visit 2: same as visit 1 |
|
| Fluoxetine | Active Comparator | Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine Visit 2: same as visit 1 |
|
| DHEA | Active Comparator | Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA Visit 2: same as visit 1 |
|
| Fluoxetine and DHEA | Active Comparator | Visit 1: Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA Visit 2: same as visit 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Tablet | Drug | There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the level of catecholamines in plasma | An average of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Screening Laboratory Tests Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maka Siamashvili, MD | Contact | 410-706-5623 | msiamashvili@som.umaryland.edu | |
| Vanessa Briscoe, PhD | Contact | vbriscoe@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen N Davis, MBBS | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000737 | Androstenols |
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Participants will be randomized into 2 groups. Group 1 will consist of a random order of Protocol 1 and Protocol 5. Group 2 will consist of a randomized order of Protocols 2, 3, 4
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|
| Placebo Oral Tablet | Drug | There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits. |
|
| Fluoxetine | Drug | There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits. |
|
| DHEA | Drug | There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits. |
|
|
| Fluoxetine and DHEA | Drug | There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits. |
|
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000736 |
| Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |