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

Not Applicable

Completed

• Conditions: Obesity, Morbid; Hypoglycemia
• Interventions: Behavioral: Regular diet; Behavioral: 10-point nutrition plan

• Registration Number: NCT05011682
• Lead Sponsor: Helse Nord-Trøndelag HF

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-18
• Study Start: 2021-08-27
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Joslin Diabetes Senter nutrition	10-point nutrition plan	all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)
Joslin Diabetes Senter nutrition	Regular diet	all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)

Primary Outcome Measures

Name	Time	Method
blood sugar variation	4 weeks	measured by continuous blood glucose monitor

Trial Locations

Locations (1)

Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos; 🇳🇴 Namsos, Trøndelag, Norway