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Completed

NCT Number: NCT05011682

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Namsos, Trøndelag, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular diet

Behavioral

participant's usual diet during 2 weeks

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

Other names: Joslin Diabetes Senter nutrition plan

Primary outcomes

  1. blood sugar variation

    Time frame: 4 weeks

    measured by continuous blood glucose monitor

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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