Hypoglycemia Associated Autonomic Failure in Type 1 DM
Completed · Not applicable · Has a placebo group
Conditions studied: Type 1 Diabetes
In brief
It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et al., 1996). Because of the increased prevalence of depression in those with diabetes, it is critical to discover what affect the antidepressant therapy may have on counterregulatory responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals more susceptible to hypoglycemia.
Key facts
- Study ID
- NCT00592670
- Run by
- Vanderbilt University
- People needed
- 48
- Starts
- 2005-03-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2014-12-11
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 16 (8 males, 8 females) healthy volunteers aged 18-45 yr
- 34 (17 males, 17 females) type 1 diabetes volunteers aged 18-45 yr
- Body mass index 21-30 kg • m-2
- Normal bedside autonomic function
- Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
- Female volunteers of childbearing potential: negative HCG pregnancy test
- Volunteers over 40 years old: normal heart tracing recorded while resting and walking on the treadmill
- For those with type 1 diabetes: HbA1c > 7.0%
- For those with type 1 diabetes: had diabetes for 2-15 years
- For those with type 1 diabetes: no clinical evidence of diabetic tissue complications
You may not qualify if…
- Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- Hemoglobin of less than 12 g/dl
- Abnormal results following screening tests
- Pregnancy
- Subjects with any indication of depression, anxiety, bipolar, panic, or eating disorders
- Subjects with a past medical history or family history of mania or bipolar disorders
- Subjects unable to give voluntary informed consent
- Subjects with a recent medical illness
- Subjects with known liver or kidney disease
- Subjects taking steroids
- Subjects taking beta blockers
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Where it is running
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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