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

H

Helse Nord-Trøndelag HF

Status

Completed

Conditions

Hypoglycemia
Obesity, Morbid

Treatments

Behavioral: 10-point nutrition plan
Behavioral: Regular diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05011682
2021/230363

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

9 participants in 1 patient group

Joslin Diabetes Senter nutrition
Experimental group
Description:
all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)
Treatment:
Behavioral: Regular diet
Behavioral: 10-point nutrition plan

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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