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Clinical Trials/NCT02542059
NCT02542059RecruitingNot Applicable

Visualizing Beta Cells in Patients With Remission of T2DM After Bariatric Surgery

Radboud University Medical Center2 sites in 1 country24 target enrollmentStarted: August 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
2
Primary Endpoint
Beta cell mass measured by uptake of 68Ga-exendin in the pancreas on PET images

Study Overview

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.

Detailed Description

Obesity and T2DM The prevalence of Type 2 Diabetes Mellitus (T2D) in the Netherlands is 600.000-800.000 and each year ~70.000 new patients are diagnosed. This increasing number of patients with T2D is closely correlated with the obesity epidemic. In women, over 50% of T2D risk can be accounted for by obesity. Also, over 85% of T2D patients are overweight and ~50% are obese.

Obese patients with T2D not only have elevated glucose levels but are also at risk to develop dyslipidemia and hypertension. This clustering of cardiovascular risk factors leads to an increased risk of micro-and macrovascular long-term complications. In fact, patients with T2D have a 2-4 times increased risk for cardiovascular disease. These complications seriously decrease the quality of life and life expectancy of T2D patients. The burden of this disease not only affects these patients but our society as well. Health care costs with respect to diabetes amounted 814 million euro in 2005 in the Netherlands and indirect costs because of absence of work are unknown but thought to be substantial.

Weight loss is perhaps the most important therapeutic intervention in obese patients with T2D. Weight loss intervenes in the underlying pathophysiology and restores insulin sensitivity and sometimes even insulin secretion. In addition, it improves dyslipidemia and hypertension. In contrast, most pharmacological interventions only relieve the symptoms of the complex disease process underlying T2DM whilst the disease process itself is not addressed and even progresses in the course of time. Unfortunately, the effect of weight loss interventions such as diet and lifestyle or even drugs is often modest (3-5 kg) and short-lived.

Bariatric surgery and T2DM remission Weight reducing surgery, i.e. bariatric surgery, is the only intervention that leads to persistent weight loss and it is superior above conventional (non-surgical) treatment.

Bariatric surgery can be divided into restrictive (gastric band) and malabsorptive procedures (biliopancreatic diversion) or a combination of the 2 (Roux-en-Y Gastric Bypass, RYGB).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

  • Comparing uptake of 68Ga-exendin in the pancreas with blood glucose and insulin measured after glucose ingestion and arginine infusion(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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