The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery

Study Overview
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Brief Summary
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This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.

Official Title
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The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study

Conditions
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Hypoglycemia, Obesity, Morbid

Intervention / Treatment
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* Behavioral: Regular diet
* Behavioral: 10-point nutrition plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery visits Namsos outpatient clinic for follow-up. having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS). at least one of these symptoms must be a neuroglycopenic symptom all these symptoms have an intensity of 2 or 3 on DSS. Exclusion Criteria: severe surgery-related complication revisional surgery life threatening health conditions. diabetes mellitus or other metabolic diseases pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are their own controls. All participants will follow their usual diet in the first 2 weeks, and then during the next 2 weeks the 10-point nutrition plan according to Joslin Diabetes Center.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joslin Diabetes Senter nutrition<br>all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks) | Behavioral: Regular diet<br>* participant's usual diet during 2 weeks<br>Behavioral: 10-point nutrition plan<br>* controlled portions of low glycemic index carbohydrates, avoidance of rapidly absorbed carbohydrates, adjustment of timing of meals and snacks, and attention to personal and cultural barriers to implementation<br>* Other names: Joslin Diabetes Senter nutrition plan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sugar variation | measured by continuous blood glucose monitor | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life