Evaluation of pancreas composition and function during return to normal glucose tolerance in type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11969319

Enrollment

Registered

2011-06-21

Start date

2011-02-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Topic: Diabetes Research Network, Metabolic and Endocrine

Interventions

1. Subjects with and without type 2 diabetes will be investigated before and after gastric bypass surgery 2. Very low calorie diet (VLCD) 3. Subjects with T2DM will be randomised into 'surgery only' o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes duration less than 15 years 2. On treatment with diet alone or diet plus oral agents 3. BMI 35-45m/kg2 4. Listed for gastric bypass surgery 5. HbA1c < 10%

Exclusion criteria

Exclusion criteria: 1. Waist circumference >150cm 2. Kidney dysfunction (serum creatinine >150 µmol/l) 3. Liver dysfunction (serum ALT > 2.5 times the upper limit of normal) 4. Contraindications to MRI (metal implants and claustrophobia) 5. Alcohol consumption >14 units per week 6. Treatment with thiazolidinediones, insulin, GLP1 analogues or steroids 7. History of bowel surgery or inflammatory bowel disease

Design outcomes

Primary

Measure	Time frame
First phase insulin response at baseline, 1 week after intervention and 8 weeks after surgery	—

Secondary

Measure	Time frame
1. Liver fat and hepatic insulin sensitivity at baseline, 1 week after intervention and 8 weeks after surgery 2. The treatment induced changes in pancreatic fat content at baseline, 1 week after intervention and 8 weeks after surgery	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026