What is the impact of a modified Roux-en-Y-gastric bypass operation on people with type 2 diabetes mellitus?

What is the impact of a modified Roux-en-Y-gastric bypass operation on people with type 2 diabetes mellitus? The LONG LIMB-2 double-blinded randomised controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65113000

Enrollment

Registered

2020-11-26

Start date

2021-03-02

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Diabetes mellitus, type 2 diabetes mellitus (T2DM), obesity Nutritional, Metabolic, Endocrine Diabetes mellitus, type 2 diabetes mellitus (T2DM), obesity

Interventions

Randomisation will take place intra-operatively. The surgeon will measure the total intestinal length and decide if the patient can be randomised intraoperatively (only patients with a total intestina

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus (T2DM) 2. Body Mass Index (BMI) >30 kg/m² 3. Aged between 18 and 65 years 4. Eligible for metabolic/bariatric surgery as per NICE guideline 189

Exclusion criteria

Exclusion criteria: 1. Current use or need for insulin 2. Unacceptably high risk for anaesthesia or surgery 3. Pregnancy/breastfeeding 4. Total small intestinal length <5.5 m

Design outcomes

Primary

Measure	Time frame
1. Glycaemic control measured using glycated haemoglobin (HbA1C) levels in blood samples taken at baseline and 12 months	—

Secondary

Measure	Time frame
1. Rate of remission of T2DM measured using routine blood tests and review of glucose lowering medications at baseline and 12 months 2. Number of glucose-lowering medications recorded at baseline and 12 months 3. Body weight recorded at baseline and 12 months 4. Arterial blood pressure measured using sphygmomanometer at baseline and 12 months 5. Lipid profile measured using fasting lipid blood tests taken at baseline and 12 months 6. Adverse events (including surgical complications, hypoglycaemia and micronutrient deficiencies) recorded between baseline and 12 months 7. Rate of intestinal absorption of ingested glucose in participants in the mechanistic study only measured using a standard Oral Glucose Tolerance Test (OGTT) at baseline and 12 months	—

Measure

Time frame

1. Rate of remission of T2DM measured using routine blood tests and review of glucose lowering medications at baseline and 12 months 2. Number of glucose-lowering medications recorded at baseline and 12 months 3. Body weight recorded at baseline and 12 months 4. Arterial blood pressure measured using sphygmomanometer at baseline and 12 months 5. Lipid profile measured using fasting lipid blood tests taken at baseline and 12 months 6. Adverse events (including surgical complications, hypoglycaemia and micronutrient deficiencies) recorded between baseline and 12 months 7. Rate of intestinal absorption of ingested glucose in participants in the mechanistic study only measured using a standard Oral Glucose Tolerance Test (OGTT) at baseline and 12 months

—

Countries

England, United Kingdom

Outcome results

None listed

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