Back to resultsThe Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
Primary Purpose
Hypoglycemia, Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Regular diet
10-point nutrition plan
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia focused on measuring Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life
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
Sites / Locations
- Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Joslin Diabetes Senter nutrition
Arm Description
all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)
Outcomes
Primary Outcome Measures
blood sugar variation
measured by continuous blood glucose monitor
Secondary Outcome Measures
Full Information
NCT ID
NCT05011682
First Posted
August 17, 2021
Last Updated
January 17, 2023
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05011682
Brief Title
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Obesity, Morbid
Keywords
Gastric bypass, Diet therapy, Blood sugar variation, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Joslin Diabetes Senter nutrition
Arm Type
Experimental
Arm Description
all participants will first follow their own usual diet (2 weeks) and then the Joslin Diabetes Senter nutrition plan (2 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Regular diet
Intervention Description
participant's usual diet during 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
10-point nutrition plan
Other Intervention Name(s)
Joslin Diabetes Senter nutrition plan
Intervention Description
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
Primary Outcome Measure Information:
Title
blood sugar variation
Description
measured by continuous blood glucose monitor
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Landstad, phd
Organizational Affiliation
Helse Nord-Trøndelag HF
Official's Role
Study Director
Facility Information:
Facility Name
Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos
City
Namsos
State/Province
Trøndelag
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery
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