Visualizing beta cells in morbid obese patients with T2D before and after bariatric surgery

Visualizing beta cells in morbid obese patients with T2D before and after bariatric surgery - Visualizing beta cells before and after bariatric surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42099

Enrollment

Registered

2016-09-20

Start date

2017-03-29

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Morbid obese T2D patient who will undergone RYGB at the Rijnstate in Arnhem (BMI > 35 kg/m2) - Female - Signed informed consent;Mild T2D group o C-peptide > 1.3 nmol/l o T2D diagnosis < 2 years before RYGB o Only metformin usage as anti-diabetic medication;Severe T2D group o C-peptide < 1 nmol/l o T2D diagnosis > 4 years before RYGB o Insulin and/or sulfonylurea (SU) usage

Exclusion criteria

Exclusion criteria: - Fasting glucose 50 kg/m2 - Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors - Pregnancy or the wish to become pregnant within 18 months - Breast feeding - Kidney failure, i.e. calculated creatinine clearance below 40ml/min - Age

Design outcomes

Primary

Measure	Time frame
The main parameter of this study is the difference in pancreatic 68Ga-exending uptake before and one year after RYGB in morbid obese patients with T2D. The pancreatic uptake is assessed by quantitative analysis of exendin-PET images.	—

Secondary

Measure	Time frame
Secondary parameters are: - the relation between the difference in pancreatic uptake of 68Ga-exendin before and after RYGB and the T2D outcome after RYGB. - the relation between pre-RYGB pancreatic uptake of 68Ga-exendin and post-RYGB T2D outcome. - the correlation between pancreatic uptake of 68Ga-exendin and beta cell function, before and after RYGB.	—

Countries

Netherlands

Outcome results