UnknownNot Applicable

Mechanisms of Post-Bariatric Hypoglycemia

United States105 participantsStarted 2020-02-26

Plain-language summary

Post-bariatric hypoglycemia (PBH) is an increasingly recognized syndrome that is incompletely understood. The purpose of this study is to increase our level of understanding by investigating mechanisms contributing to this condition. Participation in this study will take place over four visits, which will include the following: * Wearing of a continuous glucose monitoring device; * Providing a stool sample (collected at home); * Measuring glucose and hormone levels in response to a meal; * Measuring glucose and hormone levels in response to an injection of glucagon; * Measuring hormone levels while glucose levels are gradually lowered, and during a controlled period of a low glucose level (hypoglycemic clamp). Investigators will test the hypothesis that counterregulatory hormone responses are impaired in individuals with PBH, and that differences in the intestinal bacteria (microbiome) may contribute to this condition.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. For PBH group only: Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
. For post-RYGB group without PBH: Males or females with history of RYGB and no history of symptomatic hypoglycemia.
. For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
. Age 18-70 years of age, inclusive, at screening.
. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Metabolic responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing

Timeframe: July 2023

Hormonal responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing

Timeframe: July 2023

Assessment of glucagon responsiveness during glucagon stimulation testing

Timeframe: July 2023

Assessment of hormonal responses during glucagon stimulation testing

Timeframe: July 2023

Analysis of microbiome differences in patients with PBH

Timeframe: July 2023

Trial details

NCT IDNCT04428866

SponsorJoslin Diabetes Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09

View on ClinicalTrials.gov More Hypoglycemia trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. For PBH group only: Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.
. For post-RYGB group without PBH: Males or females with history of RYGB and no history of symptomatic hypoglycemia.
. For non-surgical controls only: Males or females with no history of upper gastrointestinal surgery and no history of hypoglycemia or diabetes.
. Age 18-70 years of age, inclusive, at screening.
. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion criteria

What they're measuring

Metabolic responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing

Timeframe: July 2023

Hormonal responses during experimental hypoglycemia induced by hypoglycemic clamp and/or mixed meal testing

Timeframe: July 2023

Assessment of glucagon responsiveness during glucagon stimulation testing

Timeframe: July 2023

Assessment of hormonal responses during glucagon stimulation testing

Timeframe: July 2023

Analysis of microbiome differences in patients with PBH

Timeframe: July 2023