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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05011682

Enrollment

Registered

2021-08-18

Start date

2021-08-27

Completion date

2021-12-01

Last updated

2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Obesity, Morbid

Keywords

Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life

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.

Interventions

BEHAVIORALRegular diet

participant's usual diet during 2 weeks

BEHAVIORAL10-point nutrition plan

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
blood sugar variation	4 weeks	measured by continuous blood glucose monitor

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026