Diabetes Mellitus, Type 2, NAFLD, Obesity
Conditions
Brief summary
This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of care protocol will be collection of fecal samples at 3 time points. This will enable investigators to compare changes in and effects by microbiota after low-calorie diet versus after bariatric surgery .
Interventions
None listed
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Be an eligible candidate for bariatric surgery based on standard criteria in place, have been enrolled in bariatric surgery program at Cleveland Clinic Main Campus, and have been cleared and approved for bariatric surgery by the BMI bariatric program and his/her health insurance * Have a Body Mass Index (BMI) more than 35 kg/m2 * Have type 2 diabetes (T2D) (but not type 1 diabetes, see
Exclusion criteria
) as defined by 1. If untreated (as per ADA standards of care) FPG \> or = 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h OR 2-h PG \> or = 200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR A1C \> or = 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose \> or = 200 mg/dL (11.1 mmol/L). 2. the use of any antidiabetic drug or glucose lowering agent, including biguanides (metformin), thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides, DPP4-inhibitors, GLP1-agonists, SGLT2i, any type of insulin. * Have the ability and willingness to participate in the study and agree to the study terms * As a standard of care, have a negative urine pregnancy test prior to surgery for women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in human gut microbiota | 3 months after surgery | Test for intrapersonal longitudinal changes in human gut microbiota in patients with obesity undergoing bariatric surgery at 3 time points: baseline (preoperative), after diet-induced non-surgical weight loss, and 3-months post-operative. Metagenomic characterization of gut microbial communities will be longitudinally examined with human feces at 3 time points. Microbiota profiles will be assessed in fecal samples using V4 variable regions of the 16S rRNA gene by MiSeq 250-base paired-end multiplex sequencing. Moreover, total microbial cell counts in fecal samples will be determined using flow cytometry in order to have a quantitative microbiome profiling. |
Countries
United States
Outcome results
None listed