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

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT05011682
Collaborator
Norwegian University of Science and Technology (Other)
20
Enrollment
1
Location
1
Arm
9.1
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Regular diet
  • Behavioral: 10-point nutrition plan
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Behavioral: Regular diet
participant's usual diet during 2 weeks

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
Other Names:
  • Joslin Diabetes Senter nutrition plan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. blood sugar variation [4 weeks]

      measured by continuous blood glucose monitor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos Namsos Trøndelag Norway

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Bodil Landstad, phd, Helse Nord-Trøndelag HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helse Nord-Trøndelag HF
    ClinicalTrials.gov Identifier:
    NCT05011682
    Other Study ID Numbers:
    • 2021/230363
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helse Nord-Trøndelag HF
    Gastric bypass
    Diet therapy
    Blood sugar variation
    Quality of Life
    Additional relevant MeSH terms:
    Hypoglycemia
    Obesity, Morbid

    Study Results

    No Results Posted as of Apr 5, 2022