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

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011682
• Other study ID #: 2021/230363
• Status: Completed
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2023
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Norway	Obesity Outpatient Clinic, Surgical Clinic, Nord-Trøndelag Hospital Trust, Hospital of Namsos	Namsos	Trøndelag

Sponsors (2)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood sugar variation	measured by continuous blood glucose monitor	4 weeks