Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Male or female patients 18-70 years of age

• Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)

• Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Time Frame
Start Date: 2020-05-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Experimental: Remote Phase: Post-Bariatric Hypoglycemia Patients
Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.
No_intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.
No_intervention: In-Clinic Phase: Surgical Controls
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
No_intervention: In-Clinic Phase: Nonsurgical Controls
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
No_intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube
Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.
Authors
Colleen Craig
Related Therapeutic Areas
Sponsors
Collaborators: American Diabetes Association
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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