Visualizing Beta Cells After Bariatric Surgery

NCT02542059 | Unknown

• 1 other identifier: NL51058.091.14
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

In order to evaluate the difference in beta cell mass in patients with and without complete resolution of type 2 diabetes mellitus (T2DM) after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups. These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms behind resolution of T2DM after bariatric surgery. This would be of great interest for the assessment of RYGB as an alternative therapy in patients with T2DM with a BMI \<35, who currently do not meet the international guidelines for bariatric surgery.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Beta cell mass measured by uptake of 68Ga-exendin in the pancreas on PET images

  1 year

Secondary Outcomes (1)

• Comparing uptake of 68Ga-exendin in the pancreas with blood glucose and insulin measured after glucose ingestion and arginine infusion

  1 year

Study Arms (2)

Responders

Patients with resolved type 2 diabetes after bariatric surgery, will undergo 68Ga-exendin PET/CT

Radiation: 68Ga-exendin PET/CT

Non-responders

Patients with unresolved type 2 diabetes after bariatric surgery, will undergo 68Ga-exendin PET/CT

Radiation: 68Ga-exendin PET/CT

Interventions

68Ga-exendin PET/CT RADIATION

68Ga-exendin PET/CT

Also known as: GLP-1 receptor PET/CT

Non-responders; Responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indiciduals who have undergone RYGB at least 1 year earlier at the Rijnstate Hospital in Arnhem.

You may qualify if:

• For responders:
• Obese T2D patient who had undergone RYGB at least 1 year earlier
• Signed informed consent
• Complete resolution of T2D after surgery
• For non-responders:
• Obese T2D patient who had undergone RYGB at least 1 year earlier
• Signed informed consent
• No complete resolution of T2D after surgery

You may not qualify if:

• Previous treatment with synthetic exendin
• Breast feeding
• Pregnancy or the wish to become pregnant within 6 months
• renal dysfunction
• Age \< 18 years
• Incapacitated
• No signed informed consent

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rijnstate Hospital: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

RadboudUMC

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Related Publications (1)

• Tokgoz S, Deden LN, Hofboer A, Meijer RI, Hazebroek EJ, van Bon AC, de Galan BE, Tack CJ, Boss M, Gotthardt M. Beta cell function and mass in individuals with and without remission of type 2 diabetes after Roux-en-Y gastric bypass. Diabetologia. 2026 Jan 20. doi: 10.1007/s00125-025-06659-1. Online ahead of print.

  PMID: 41555052 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Martin Gotthardt, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marti Boss, Msc

CONTACT

+31-24-36; marti.boss@radboudumc.nl

Martin Gotthardt, Prof. Dr.

CONTACT

+31-24-36; martin.gotthardt@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 4, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

NL (2)