Clinical trial NCT02550145: Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery
Official title: The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypoglycemia
Keywords: Hyperinsulinemic
post-bariatric surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma glucose area under the curve
timeFrame: 0 to 180 minutes
Secondary outcomes:
measure: Plasma insulin area under the curve
timeFrame: 0 to 180 minutes
Other outcomes:
measure: Hypoglycemia symptom score
timeFrame: 0-180 minutes
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Colleen Craig, M.D.
role: STUDY_DIRECTOR
References:
citation: Craig CM, Liu LF, Deacon CF, Holst JJ, McLaughlin TL. Critical role for GLP-1 in symptomatic post-bariatric hypoglycaemia. Diabetologia. 2017 Mar;60(3):531-540. doi: 10.1007/s00125-016-4179-x. Epub 2016 Dec 14.