Recruiting NA Diabetes Mellitus Type 2

Compares treatment options for Diabetes Mellitus Type 2

Official title Effects on Remission of Type 2 Diabetes Mellitus Following Gastric Bypass Alone vs Gastric Bypass Combined With Truncal Vagotomy

ClinicalTrials.gov ID: NCT07278115

What this study is testing

What it's testing
This randomized, triple-blind clinical trial investigates whether adding truncal vagotomy to Roux-en-Y gastric bypass (RYGB) enhances remission of type 2 diabetes mellitus (T2DM) in patients with obesity. The study explores whether modulation of vagal signaling provides superior metabolic outcomes compared to standard RYGB alone.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 68

You may be able to join if

  • BMI ≥ 30 kg/m²
  • Age: 18-68 years
  • Confirmed type 2 diabetes mellitus with:
  • HbA1c ≥ 6.5%, or
  • HbA1c ≥ 6.1% and the use of antidiabetic medication

You likely can't join if

  • Previous bariatric surgery or major abdominal surgery (e.g., enterectomy, gastrectomy, colectomy, hepatectomy, partial or total pancreatectomy)
  • Major, uncompensated health problems (major psychiatric, endocrine, cardiac, pulmonary, hepatic, or renal disorder; cancer; or other conditions with...
  • Use of corticosteroids (glucocorticoids):
  • Chronic corticosteroid use for \> 3 months within the last year, or
  • Corticosteroid therapy within the last 3 months
  • Type 1 diabetes mellitus
See the full eligibility criteria
Who can join
  • BMI ≥ 30 kg/m²
  • Age: 18-68 years
  • Confirmed type 2 diabetes mellitus with:
  • HbA1c ≥ 6.5%, or
  • HbA1c ≥ 6.1% and the use of antidiabetic medication
  • Advanced-DiaRem Score \> 5\ \ Advanced-DiaRem Score: a validated scoring system predicting diabetes remission after bariatric surgery.
What rules you out
  • Previous bariatric surgery or major abdominal surgery (e.g., enterectomy, gastrectomy, colectomy, hepatectomy, partial or total pancreatectomy)
  • Major, uncompensated health problems (major psychiatric, endocrine, cardiac, pulmonary, hepatic, or renal disorder; cancer; or other conditions with increased risk of complications)
  • Use of corticosteroids (glucocorticoids):
  • Chronic corticosteroid use for \> 3 months within the last year, or
  • Corticosteroid therapy within the last 3 months
  • Type 1 diabetes mellitus
  • Alcohol or drug addiction

The study team makes the final eligibility decision.

Where it's taking place

  • Athens, Attica, Greece

Compensation & support

A stipend or compensation may be offered.

Compensation likely.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 68 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Athens, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.