How is glucose variability changed among people having metabolic surgery, and how does this affect pregnancy and its outcomes?

Observational study on glucose variability after metabolic surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10336129

Enrollment

1254

Registered

2025-09-16

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

Glucose variability after metabolic surgery Surgery

Interventions

Study 1: Metabolic Surgery: Participants will be recruited prior to undergoing surgery for Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG) or Mini Gastric Bypass (MGB). They will undergo bli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study 1: 1. Male or female 2. Aged 18 years upwards 3. Can be diagnosed with diabetes mellitus, pre-diabetes or normal glucose tolerance on basis of WHO 2006 and 2011 criteria Study 2: 2A: Participants who have undergone metabolic surgery =18 months ago and a control group consisting of non-surgical pregnant participants who are gestational age and pre-conception weight-matched. 2B: Participants who have undergone metabolic surgery <18 months ago and a control group consisting of non-surgical pregnant participants who are gestational age and pre-conception weight-matched.

Exclusion criteria

Exclusion criteria: 1. Health condition that would, in the opinion of the investigators, prevent the subject from participating in the study safely 2. Unable or unwilling to wear CGM sensor equipment 3. Previous sensitivity to components of the CGM sensor equipment (for example, the adhesive used for the sensor)

Design outcomes

Primary

Measure	Time frame
Glucose variability (GV) is measured using continuous glucose monitoring (CGM) which provides information on mean glucose, Coefficient of Variation, mean amplitude of glycaemic excursions (MAGE), continuous overlapping net glycaemic action (CONGA) and in time in euglycaemic range of 3.5-7.8 mmol/L. Study 1: measured at baseline (pre-surgery), 1 month after surgery, 3 months after surgery, 12 months after surgery, 24-36 months after surgery, 60 months and 10 years after surgery. Study 2: measured at preconception, 1st, 2nd and 3rd trimesters, and postpartum.	—

Measure

Time frame

Glucose variability (GV) is measured using continuous glucose monitoring (CGM) which provides information on mean glucose, Coefficient of Variation, mean amplitude of glycaemic excursions (MAGE), continuous overlapping net glycaemic action (CONGA) and in time in euglycaemic range of 3.5-7.8 mmol/L. Study 1: measured at baseline (pre-surgery), 1 month after surgery, 3 months after surgery, 12 months after surgery, 24-36 months after surgery, 60 months and 10 years after surgery. Study 2: measured at preconception, 1st, 2nd and 3rd trimesters, and postpartum.

—

Secondary

Measure	Time frame
Metabolic profiling data including weight, blood, urine and stool samples: Study 1: measured at baseline (pre-surgery), 1 month after surgery, 3 months after surgery, 12 months after surgery, 24-36 months after surgery, 60 months and 10 years after surgery. Study 2: measured at preconception, 1st, 2nd and 3rd trimesters, and postpartum.	—

Countries

England, United Kingdom

Contacts

Public ContactRajalakshmi Valaiyapathi

rv1212@ic.ac.uk+44 (0)7712 485272

Outcome results

None listed

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