L-Cell Activity in Small Intestine as Biliopancreatic Loop in Obese Patients With DM2 Submitted to RYGBP

What Was Tested

The trial (not phased) is built around Peptide YY.

Several procedures and interventions are used in its treatment, and the most efficient and with a positive impact on the life of patients with severe obesity and DM2 is Bariatric Surgery.

The objective of is analyze the activity of L cells according to the extension of the bilio-pancreatic loop in T2DM patients undergoing GDYR.

It had 1 arm (groups): Prospective analisys (other).

The registry classes the interventions as other.

More on the Plan

Patients were evaluated preoperatively (T0) and 6 months (T1) after GDYR.

INTRODUTION: Patients with obesity have a suppressed incretin effect and a consequent imbalance of glycemic homeostasis.

They play key roles in stimulating the secretion of insulin by the endocrine pancreas .

It is therefore of considerable importance to understand the secretion mechanisms of epithelial intestinal cells as well as the identity and location of cells responsible for the action of these peptides .

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Above 18 to 65 years. BMI ≥ 35 kg/m2. Presence of DM2:. C-peptide ≥ 3 ng/dl.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: corticosteroid use; hepatitis b and c or hiv carriers; previous abdominal or bariatric surgery.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Peptide YY was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-02-05 with completion listed for 2022-07-07.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes number of active L cells (time frame: Before and 6 moths after bariatric surgery). Changes mRNA expression levels of active L cells (time frame: Before and 6 moths after bariatric surgery).

What This Means in Plain Language

Put simply, this is a not phased trial of Peptide YY in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Peptide YY compound page, all human trials.