Phase 2
N=12
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02762708 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Fasting Glucose — 6.1; 7.23; 6.48; 5.89 mmol/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Roux-en-Y Gastric Bypass (RYGB) (Procedure); Caloric Restriction (Behavioral); Exendin-9,39 (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Glucose |
4.75 | — |
| PRIMARY Fasting Glucose |
4.75 | — |
| PRIMARY Peak Glucose |
8.15 | — |
| PRIMARY Peak Glucose |
8.15 | — |
| PRIMARY Glucose AUC |
2815; 2715; 3146; 2380 | — |
| PRIMARY Changes in the Gut Microbiome Following RYGB or Caloric Restriction |
— | — |
Summary
What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?
Eligibility Criteria
Inclusion Criteria
- Age 20-65 years of age.
- Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
- Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.
Exclusion Criteria
- Previous treatment with thiazolidinediones.
- Chronic antibiotic therapy.
- Active microvascular or macrovascular complications of diabetes.
Data sourced from ClinicalTrials.gov (NCT02762708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.