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

NCT ID: NCT05011682

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2021-12-01

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.

Conditions

Hypoglycemia; Obesity, Morbid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Joslin Diabetes Senter nutrition

all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)

Group Type: EXPERIMENTAL

Regular diet

Intervention Type: BEHAVIORAL

participant's usual diet during 2 weeks

10-point nutrition plan

Intervention Type: BEHAVIORAL

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

Interventions

Regular diet

participant's usual diet during 2 weeks

Intervention Type: BEHAVIORAL

10-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

Intervention Type: BEHAVIORAL

Other Intervention Names

Joslin Diabetes Senter nutrition plan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bodil Landstad, phd

Role: STUDY_DIRECTOR

Helse Nord-Trøndelag HF

Locations

Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos

Namsos, Trøndelag, Norway

Countries

Norway

Other Identifiers

2021/230363

Identifier Type: -

Identifier Source: org_study_id