Hypoglycemia
Conditions
Keywords
Hyperinsulinemic, post-bariatric surgery
Brief summary
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
Detailed description
The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role. The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.
Interventions
DRUGExendin (9-39)
IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).
OTHERPlacebo
IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)
Sponsors
Tracey McLaughlin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women ages 18-65 * BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery
Exclusion criteria
* Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week * History of cardiac failure, renal insufficiency (estimated Crcl\<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct\<30%), or uncontrolled hypertension (SBP\>160 or DBP\>100) * Pregnancy * Use of medications that affect glucose metabolism * Fasting glucose \>150 or HbA1c\>7.5 on Metformin * Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera) * Active, uncontrolled psychiatric disease * Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose area under the curve | 0 to 180 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Plasma insulin area under the curve | 0 to 180 minutes |
Other
| Measure | Time frame |
|---|---|
| Hypoglycemia symptom score | 0-180 minutes |
Countries
United States
Outcome results
None listed