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Hypoglycemia | Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Hypoglycemia research study

What is the primary objective of this study?

The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce the frequency and severity of hypoglycemia in individuals who have had gastric bypass surgery.

Who is eligible to participate?

Inclusion Criteria: - severe hypoglycemic episodes post-gastric bypass surgery - normal fasting glucose - age 21 to 65 - hypoglycemia must not have responded to dietary intervention (low glycemic index, controlled carbohydrate portions) and a trial of acarbose therapy at the maximally tolerated dose Exclusion Criteria: - Hypoglycemia in the fasting state (greater than 12 hours fast) - History of preoperative diabetes mellitus - Use of medications that affect gastrointestinal motility (e.g., cisapride, metoclopramide) - Impaired renal function (creatinine clearance < 20 ml/min or on dialysis - Hepatic disease (defined as liver enzymes > 2 times upper normal limit for ALT and AST) - Blood donation for 2 months prior to the study. - Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or neuroglycopenic symptoms of hypoglycemia despite detailed education

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypoglycemia

Evidence of Previous Gastric Surgery

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PramlintideSee description above (arm description).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pramlintide (Symlin)Participants in this study will be asked to complete 4 study visits. Study visit 1 will be for screening. Eligible individuals who provide informed consent will be asked to keep a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At study visit 2, a baseline mixed meal tolerance test will be performed. Glucose, hormonal responses, and satiety will be assessed. Glucose and symptom log will be reviewed. Pramlintide will be prescribed, with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants will keep a record of all hypoglycemic symptoms and blood glucose measurements at those times. Study visit 3 will occur at week 4 of treatment and focus on evaluation of symptoms and side effects. Participants will again complete a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants will undergo a repeat mixed meal tolerance test.

Study Status

Active, not recruiting

Start Date: June 2013

Completed Date: October 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Hypoglycemia

Secondary Outcome: meal hormonal responses

Study sponsors, principal investigator, and references

Principal Investigator: Mary E. Patti, MD

Lead Sponsor: Joslin Diabetes Center

Collaborator: Bristol-Myers Squibb

More information:https://clinicaltrials.gov/show/NCT01841359

Patti ME, Goldfine AB. Hypoglycaemia following gastric bypass surgery--diabetes remission in the extreme? Diabetologia. 2010 Nov;53(11):2276-9. doi: 10.1007/s00125-010-1884-8. Epub 2010 Aug 21.

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