Gastrointestinal hormones and genes associated to type 2 diabetes remission in non-morbid obesity after bariatric surgery

Role of gastrointestinal hormones and genes associated to type 2 diabetes remission in non-morbid obesity after bariatric surgery. A multicentric, randomized trial using different bariatric techniques.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57114193

Enrollment

Registered

2013-05-03

Start date

2013-01-02

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Eligible patients with T2D and grade 1 obesity will be randomized to undergo either gastric bypass (RYGB) (performed laparoscopically, with a 150 cm-alimentary limb and a 100-cm-biliopancreatic limb)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women 2. Ages 35-60 3. Type 2 diabetes diagnosed 1-10 years prior to recruitment 4. Body mass index (BMI) 30-40 kg/m2 5. C-peptide level > 1 ng/dL 6. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. HbA1c levels > 6.5% or > 10% at the time of recruitment 2. Creatinine levels > 1.5 mg/dL 3. Ongoing pregnancy, either at the time of recruitment or follow-up 4. Renal failure (ClCr < 50 mL/min) 5. Liver disease 6. Psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Remission of type 2 diabetes after metabolic surgery, defined as two categories: complete remission (fasting glucose < 100 mg/dl, normal HbA1c values) and partial remission (fasting glucose 100-125 mg/dl, HbA1c < 6.5%), in both cases in the absence of active pharmacologic treatment, at each time of follow-up (T1 and T2)	—

Secondary

Measure	Time frame
1. Changes in gastrointestinal hormones (ghrelin, insulin, glucagon, GIP, GLP-1, PYY3-36, oxyntomodulin, adiponectin, leptin and GLP-2) using values of area under the curve (AUC), for each bariatric procedure and comparison with a matched control group 2. Analysis of polymorphisms involved in type 2 diabetes and incretin metabolism	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026