Longitudinal Assessment of Bariatric Surgery Sub-Study

NCT02985853 | Unknown DMC

• 3 other identifiers: IRB00003207U01DK066557U01DK066555-08
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Conditions

Obesity; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Weight

  Weight measurements will take place at every visit, up to 72 months after bariatric surgery.

  Up to 72 months

• Capillary Blood Glucose

  Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.

  Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.

You may qualify if:

• Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
• Enrollment in LABS-1 or LABS-2.
• Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
• Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
• Adequate IV access.

You may not qualify if:

• Informed consent not obtained.
• Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
• Creatinine greater than 1.7.
• Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
• Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 7, 2016
• Study Start: March 1, 2008
• Primary Completion: February 15, 2021
• Study Completion: September 1, 2024
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share