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Clinical Trials/NCT05011682
NCT05011682
Completed
Not Applicable

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

Helse Nord-Trøndelag HF1 site in 1 country9 target enrollmentAugust 27, 2021

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.

Registry
clinicaltrials.gov
Start Date
August 27, 2021
End Date
December 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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