At the University of Maryland, researchers are conducting a double blind study of the effects of SSRI medication fluoxetine (Prozac) on the Autonomic nervous system (ANS) for people with type 1 diabetes during exercise. The motivation behind this study is the fear that many people with type 1 diabetes have to exercise and induce hypoglycemia (low blood sugar). Coincidentally, reduced ANS responses produce sexual dimorphism during exercise in both people with type 1 diabetes and healthy adults. Per this “coincidence”, researchers wonder if pathways that deal with serotonin flow and activity may regulate ANS production. Since fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and increases serotonin flow, it is plausible that its use could reduce ANS responses during exercise.
This study is classified as interventional (participants receive treatment, referred to as “interventions”), randomized (participants are chosen by chance for treatment), and double blind (neither the participant nor the investigator knows the identity of the variable, i.e. who is given treatment). It consists of two trials: Trial 1 as ‘Active Comparator’ with an SSRI; and Trial 2 as Placebo Comparator without administration of SSRI. A seemingly simple study of these two trials attempts to conclude whether SSRI medication may reduce ANS occurrences during exercise and the fear of hypoglycemia.
Sixty-hour participants will be researched in this study (thirty-two healthy adults between ages of 18-45, thirty-two type 1 diabetic patients between ages of 18-45). In each of the two groups of 32 individuals, there will be 16 male and 16 female. The range of HbA1c for participants should be between 6 and 10 percent. To be included in the group of type 1 diabetics, each must have received and prove an official diagnosis of type 1 diabetes. While type 1 diabetics, the participants cannot have clinical diagnosis of diabetic tissue complications retinopathy, neuropathy, stasis ulcers, and more. For all participants their body mass index (BMI) must be less than 40 kilograms.
While it is not difficult to meet the inclusion criteria to be a patient in the study, the exclusion criteria is more extensive. It includes pregnant women, people who cannot give voluntary consent, have a history of hypertension, heart disease, or cerebrovascular incidents, have anemia or bleeding diathesis, those with recent mental illness (what qualifies as “recent” is not stated), and smokers. Additionally, to not interfere with results from fluoxetine treatment, people who take certain medications including anticoagulants, non-selective beta blockers, sedatives/hypnotics, anticonvulsants, antipsychotics, antidepressants, mood stabilizers, and antiparkinsonian drugs are excluded.
The University of Maryland is the primary sponsor of this study, with assistance from others. The National, Heart, Lung, and Blood (NHLB) Institute also contributes to the research and work performed. The main researcher attributed to the study is Stephen N. Davis, MBBS, of the University of Maryland.
Clinical TrialsView All
Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes
The University of Alabama at Birmingham is studying how a healthy diet can p
SweetMama: Testing of Technology for Diabetes Education for Pregnant Women
SweetMama is a new technological tool created to provide education for expecting mothers with type 2 diabetes. Inve
Transition to Adult Care in Type 1 Diabetes
The roles of care professional and support networks can change as teenagers with type 1 diabetes transition into ad
Veteran Support and Resources for Diabetes
This study aims to see if veterans with diabetes can navigate the state’s many available resources better wit
Emory Latino Diabetes Education Program
Latinos have an alarmingly high rate of developing diabetes as the largest United States minority group. This is wh
Nutrition Education Intervention for Adults With Type 2 Diabetes
The goal of this study is to implement a nutrition education intervention for adults with type 2 diabetes mellitus adapted from a primary health ca
Estrogen and Diabetes
It has been proven women with type 1 diabetes have a 2 to 3 fold greater risk of cardiovascular disease (CVD) than men. This study attempts to dete