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

NCT05011682 | Completed

• 1 other identifier: 2021/230363
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• blood sugar variation

  measured by continuous blood glucose monitor

  4 weeks

Study Arms (1)

Joslin Diabetes Senter nutrition

EXPERIMENTAL

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

Behavioral: Regular diet; Behavioral: 10-point nutrition plan

Interventions

Regular diet BEHAVIORAL

participant's usual diet during 2 weeks

Joslin Diabetes Senter nutrition

10-point nutrition plan 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

Also known as: Joslin Diabetes Senter nutrition plan

Joslin Diabetes Senter nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe surgery-related complication
• revisional surgery
• life threatening health conditions.
• diabetes mellitus or other metabolic diseases
• pregnancy or breast feeding

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

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

Namsos, Trøndelag, Norway

Location

MeSH Terms

Conditions

Hypoglycemia; Obesity, Morbid

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bodil Landstad, phd

  Helse Nord-Trøndelag HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 18, 2021
• Study Start: August 27, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)