Type 1 Diabetes
Conditions
Brief summary
The study is designed as an open labeled pilot trial to analyze the acute responses of glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide (Byetta) 5 mcg sc. The investigators will also test the effects of Exenatide on gastric emptying during the MMTT.
Interventions
DRUGExenatide
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
No
Inclusion criteria
* T1D of at least 3 yrs duration. * Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria. * HgbA1c\<9% * Insulin requirement of \< 0.8 U/kg/d * Absence of severe hypoglycemia in the past 6 months * Absence of ketoacidosis in the past 6 months * Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period. * Signed informed consent..
Exclusion criteria
* Inability or unwillingness to give informed consent. * Prior Exenatide or Liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status * Known hypersensitivity to Exenatide or any product components * Participation in an investigational treatment trial within the last 6 weeks before enrollment. * Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune disease except treated and stable thyroid disease * Known severe renal impairment, end-stage renal disease or renal transplantation. * Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma. * Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment. * Active clinically serious infections. * Positive pregnancy test in menstruating women or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production. | Each patients is estimated to finish the study within 4-6 weeks | We will measure the hormonal and metabolic changes during a mixed meal and intravenous glucose tolerance test with and without exenatide pretreatment in subjects with and without residual insulin production. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of exenatide on insulin secretion, glucagon secretion, GLP-1 and GIP levels, and gastric emptying in these patients with T1D. - effect of exenatide on residual insulin production | 4-6 weeks | In addition to measuring the levels of glucose and gastric emptying, we will measured glucagon levels, insulin secretion rates, GLP-1 and GIP hormonal levels during the provocative tests. |
Countries
United States
Outcome results
None listed