Aerobic exercise and hypoglycaemia (low blood sugar) after Roux-en-Y gastric bypass

The effect of acute aerobic exercise on the time spent in hypoglycaemia after Roux-en-Y gastric bypass

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17674908

Enrollment

Registered

2021-10-29

Start date

2022-02-21

Completion date

Unknown

Last updated

2026-05-19

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

Conditions

The effect of exercise on recovery from gastric bypass surgery Other

Interventions

This is a single centre, randomised, two-period, crossover study with the following experimental period sequences: AEX intervention: prolonged sitting for ˜6 hours (h) 15 minutes (min) punctuated by 3

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years but less than 75 years 2. Subjects >=1 year after gastric bypass (RYGB) 3. Able to understand written and spoken English 4. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 19/01/2023: 1. A current diagnosis of type 2 diabetes (defined as HbA1C =6.5% at screening blood tests or HbA1C = 160mmHg or Diastolic blood pressure > = 100mmHg at screening 9. Individuals which are taking part in regular structured exercise 10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia 11. History of epilepsy 12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests 13. Haemoglobin (Hb) 180 kg at screening due to the maximum weight capacity of the treadmill 18. Participating in another research study involving intervention within 3 months of screening Previous exclusion criteria: 1. A history of diabetes mellitus (type 1 or type 2 diabetes mellitus) 2. An eGFR value of = 160mmHg or Diastolic blood pressure > = 100mmHg at screening 9. Individuals which are taking part in regular structured exercise 10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia 11. History of epilepsy 12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests 13. Haemoglobin (Hb) 180 kg at screening due to the maximum weight capacity of the treadmill 18. Participating in another research study involving intervention within 3 months of screening

Design outcomes

Primary

Measure	Time frame
% time in hypoglycaemia (defined as interstitial glucose levels <3.0mmol/l) in continuous glucose monitoring after RYGB during the 24-h period after completion of the intervention.	—

Secondary

Measure	Time frame
1. Difference in Area Under the Curve (AUC)(0-180), pre-meal, peak and nadir glucose levels after mixed meal tolerance test (3-h MMTT) between the two interventions (AEX vs control) after RYGB. 2. Difference in AUC(0-180) insulin, pre-meal and peak insulin levels during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 3. Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 4. Difference in the ratio AUC(0-30) insulin/AUC(0-30) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 5. Difference in the ratio AUC(60-180) insulin/AUC(60-180) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 6. Difference in the ratio of maximum/minimum plasma glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 7. Difference at the number of mixed meal tests required to be stopped due to symptomatic HYPO with blood glucose/capillary glucose levels 7.8 mmol/l in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 16. Difference in % time interstitial glucose >10 mmol/l in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 17. Difference in the mean interstitial glucose in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 18. Difference in the standard deviation (SD) of the mean interstitial glucose between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 19. Difference in the coefficient of variation (CV) (CV=SD/mean interstitial glucose) between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 20. Difference in the frequency and intensity of	—

Measure

Time frame

1. Difference in Area Under the Curve (AUC)(0-180), pre-meal, peak and nadir glucose levels after mixed meal tolerance test (3-h MMTT) between the two interventions (AEX vs control) after RYGB. 2. Difference in AUC(0-180) insulin, pre-meal and peak insulin levels during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 3. Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 4. Difference in the ratio AUC(0-30) insulin/AUC(0-30) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 5. Difference in the ratio AUC(60-180) insulin/AUC(60-180) glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 6. Difference in the ratio of maximum/minimum plasma glucose during the 3-h MMTT between the two interventions (AEX vs control) after RYGB. 7. Difference at the number of mixed meal tests required to be stopped due to symptomatic HYPO with blood glucose/capillary glucose levels 7.8 mmol/l in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 16. Difference in % time interstitial glucose >10 mmol/l in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 17. Difference in the mean interstitial glucose in CGM between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 18. Difference in the standard deviation (SD) of the mean interstitial glucose between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 19. Difference in the coefficient of variation (CV) (CV=SD/mean interstitial glucose) between the two interventions (AEX vs control) after RYGB during the 24-h period after completion of the intervention. 20. Difference in the frequency and intensity of

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026