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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoglycemia
- Sponsor
- Helse Nord-Trøndelag HF
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- blood sugar variation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
blood sugar variation
Time Frame: 4 weeks
measured by continuous blood glucose monitor