Bariatric surgery and type 1 diabetes mellitus

Long-term outcomes in morbidly obese type 1 diabetic patients undergoing bariatric surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN49980913

Enrollment

Registered

2016-04-12

Start date

2013-12-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

1. Morbid obesity 2. Type 1 and type 2 diabetes mellitus Nutritional, Metabolic, Endocrine

Interventions

Systematic review of cases with T1DM who had undergone bariatric surgery. Detailed clinical and biochemical data were retrospectively collected by reviewing the medical charts. Patients were compared

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with T1DM according to ADA criteria, with biochemical data available with a minimum follow-up after surgery of 12 months after bariatric surgery 2. Patients with T2DM with insulin treatment before surgery and matched for initial BMI and HbA1c with T1DM group in a proportion 2:1

Exclusion criteria

Exclusion criteria: 1. Diabetes secondary to pancreatic injury or other disease (Cushing´s syndrome or acromegaly) 2. Follow- up < 12 months after bariatric surgery 3. Absence of biochemical data available (HbA1c) before and/or 12 months after surgery 4. Patient refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
1. Metabolic control changes, measured using HbA1c values at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with HbA1c values in morbidly obese Type 2 DM patients with the same follow-up 2. Anthropometric changes using weight and total weight loss percentage at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with weight changes in morbidly obese Type 2 DM patients with the same follow-up 3. Changes in insulin requirements measured using insulin dose (UI/kg body weight) at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with insulin dose (UI/kg body weight) in morbidly obese Type 2 DM patients with the same follow-up	—

Measure

Time frame

1. Metabolic control changes, measured using HbA1c values at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with HbA1c values in morbidly obese Type 2 DM patients with the same follow-up 2. Anthropometric changes using weight and total weight loss percentage at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with weight changes in morbidly obese Type 2 DM patients with the same follow-up 3. Changes in insulin requirements measured using insulin dose (UI/kg body weight) at 1,2,3,4 and 5 years after bariatric surgery in morbidly obese type 1 DM patients. Comparison with insulin dose (UI/kg body weight) in morbidly obese Type 2 DM patients with the same follow-up

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Secondary

Measure	Time frame
1. Changes in hypertension prevalence measured using percentage of patients with hypertension treatment at 5 years after bariatric surgery in T1DM and T2DM 2. Changes in dyslipidemia prevalence measured using percentage of patients with dyslipidemia treatment at 5 years after bariatric surgery in T1DM and T2DM 3. Changes in obstructive sleep apnea prevalence measured using percentage of patients with obstructive sleep apnea treatment at 5 years after bariatric surgery in T1DM and T2DM 4. Changes in diabetic microvascular complications measured using urinary albumin excretion rate in 24 h urine and retinal photographs in type 1 DM patients at 1,2,3, 4 and 5 years after bariatric surgery 5. Prevalence of diabetic acute complications in Type 1 DM measured using percentage of patients with severe hypoglycemic episodes, ketosis and ketoacidosis at 1,2,3,4,5 years after surgery 6. Differences in metabolic and weight outcomes among bariatric techniques measured using HbA1c, weight and insulin dose reduction at 12 months in type 1 DM according to the type of bariatric procedure undergone	—

Measure

Time frame

1. Changes in hypertension prevalence measured using percentage of patients with hypertension treatment at 5 years after bariatric surgery in T1DM and T2DM 2. Changes in dyslipidemia prevalence measured using percentage of patients with dyslipidemia treatment at 5 years after bariatric surgery in T1DM and T2DM 3. Changes in obstructive sleep apnea prevalence measured using percentage of patients with obstructive sleep apnea treatment at 5 years after bariatric surgery in T1DM and T2DM 4. Changes in diabetic microvascular complications measured using urinary albumin excretion rate in 24 h urine and retinal photographs in type 1 DM patients at 1,2,3, 4 and 5 years after bariatric surgery 5. Prevalence of diabetic acute complications in Type 1 DM measured using percentage of patients with severe hypoglycemic episodes, ketosis and ketoacidosis at 1,2,3,4,5 years after surgery 6. Differences in metabolic and weight outcomes among bariatric techniques measured using HbA1c, weight and insulin dose reduction at 12 months in type 1 DM according to the type of bariatric procedure undergone

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026