Are gut hormone changes the reason why the long-limb gastric bypass is more effective than the standard limb gastric bypass in improving type 2 diabetes mellitus?

Are gut hormone changes the reason why the long-limb gastric bypass is more effective than the standard limb gastric bypass in improving type 2 diabetes mellitus? A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15283219

Enrollment

Registered

2015-07-30

Start date

2015-07-31

Completion date

Unknown

Last updated

2023-08-28

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

Conditions

Topic: Diabetes

Interventions

Bariatric surgery, either the standard-limb or long-limb gastric bypass Study Entry : Registration and one or more randomisations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both genders 2. Age 18-70 years 3. Type 2 diabetes mellitus 4. Obesity 5. HbA1c>7.0% 6. On glucose-lowering medication

Exclusion criteria

Exclusion criteria: 1. Contraindications to bariatric surgery 2. Type 1 diabetes 3. Pregnancy or breastfeeding 4. Recent blood donation

Design outcomes

Primary

Measure	Time frame
Current primary outcomes as of 29/04/2019: Peak plasma GLP-1 concentration as measured by laboratory assays at baseline and at 2 weeks after intervention. Previous primary outcomes as of 10/01/2017: Mechanistic primary outcome: Peak plasma GLP-1 level as measured by laboratory assays at baseline and at the point of 20% weight loss. Clinical primary outcome: Glycated haemoglobin (HbA1c) as measured by laboratory assays at baseline and 1 year. Previous primary outcome: Change in peak GLP-1 level; Timepoint(s): After the mixed meal tolerance test.	—

Measure

Time frame

Current primary outcomes as of 29/04/2019: Peak plasma GLP-1 concentration as measured by laboratory assays at baseline and at 2 weeks after intervention. Previous primary outcomes as of 10/01/2017: Mechanistic primary outcome: Peak plasma GLP-1 level as measured by laboratory assays at baseline and at the point of 20% weight loss. Clinical primary outcome: Glycated haemoglobin (HbA1c) as measured by laboratory assays at baseline and 1 year. Previous primary outcome: Change in peak GLP-1 level; Timepoint(s): After the mixed meal tolerance test.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 29/04/2019: 1. Plasma levels of glucose, insulin, c-peptide, gut hormones, bile acids, FGF-19 and 21 after the mixed meal tolerance test are measured using laboratory assays at baseline, within 2 weeks and at the point of 20% weight loss 2. Rate of glucose appearance (Ra) and disposal (Rd) in the euglycaemic hyperinsulinaemic clamp is measured using mass spectroscopy/metry at baseline, within 2 weeks and at the point of 20% weight loss. 3. Faecal caloric content is measured using calorimetry at baseline, 20% weight loss and at 1 year 4. 4. Blood, urine and faecal microbial diversity and metabolomics are measured using mass spectroscopy/metry at baseline, within 2 weeks and at the point of 20% weight loss. 5. Total caloric intake and macronutrient composition is measured using dietary records at baseline and at 1 year 6. HbA1c is measured using by laboratory assays at baseline and 1 year 7. Total number of medications are measured using health records at baseline and 1 year 8. Rate of patients achieving diabetes remission is measured using HbA1c and number of medications at 1 year 9. Body weight is measured using scales at baseline and 1 year 10. Systolic, diastolic blood pressure and pulse are measured using a sphygmomanometer at baseline and 1 year 11. Serum fasting lipids are measured using laboratory assays at baseline and 1 year 12. Medical, surgical, nutritional and psychological complications are measured using health records at 1 year 13. Adverse events are measured using health records at 1 year 14. Glycated haemoglobin (HbA1c) as measured by laboratory assays at baseline and 1 year. Previous secondary outcome measures: 1. Plasma levels of glucose, insulin, c-peptide, gut hormones, bile acids, FGF-19 and 21 after the mixed meal tolerance test are measured using laboratory assays at baseline, within 2 weeks and at the point of 20% weight loss 2. Rate of glucose appearance (Ra) and disposal (Rd) in the euglycaemic hyp	—

Measure

Time frame

Current secondary outcome measures as of 29/04/2019: 1. Plasma levels of glucose, insulin, c-peptide, gut hormones, bile acids, FGF-19 and 21 after the mixed meal tolerance test are measured using laboratory assays at baseline, within 2 weeks and at the point of 20% weight loss 2. Rate of glucose appearance (Ra) and disposal (Rd) in the euglycaemic hyperinsulinaemic clamp is measured using mass spectroscopy/metry at baseline, within 2 weeks and at the point of 20% weight loss. 3. Faecal caloric content is measured using calorimetry at baseline, 20% weight loss and at 1 year 4. 4. Blood, urine and faecal microbial diversity and metabolomics are measured using mass spectroscopy/metry at baseline, within 2 weeks and at the point of 20% weight loss. 5. Total caloric intake and macronutrient composition is measured using dietary records at baseline and at 1 year 6. HbA1c is measured using by laboratory assays at baseline and 1 year 7. Total number of medications are measured using health records at baseline and 1 year 8. Rate of patients achieving diabetes remission is measured using HbA1c and number of medications at 1 year 9. Body weight is measured using scales at baseline and 1 year 10. Systolic, diastolic blood pressure and pulse are measured using a sphygmomanometer at baseline and 1 year 11. Serum fasting lipids are measured using laboratory assays at baseline and 1 year 12. Medical, surgical, nutritional and psychological complications are measured using health records at 1 year 13. Adverse events are measured using health records at 1 year 14. Glycated haemoglobin (HbA1c) as measured by laboratory assays at baseline and 1 year. Previous secondary outcome measures: 1. Plasma levels of glucose, insulin, c-peptide, gut hormones, bile acids, FGF-19 and 21 after the mixed meal tolerance test are measured using laboratory assays at baseline, within 2 weeks and at the point of 20% weight loss 2. Rate of glucose appearance (Ra) and disposal (Rd) in the euglycaemic hyp

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Countries

England, United Kingdom

Contacts

Public ContactAlex Miras

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026