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Register:	ISRCTN
Last refreshed on:	5 January 2021
Main ID:	ISRCTN49980913
Date of registration:	12/04/2016
Prospective Registration:	No
Primary sponsor:	Spanish Society of Endocrinology and Nutrition (SEEN)
Public title:	Bariatric surgery and type 1 diabetes mellitus
Scientific title:	Long-term outcomes in morbidly obese type 1 diabetic patients undergoing bariatric surgery
Date of first enrolment:	01/12/2013
Target sample size:	90
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN49980913
Study type:	Observational
Study design:	Multicenter, retrospective observational study (Other)
Phase:	Not Applicable

Countries of recruitment
Spain

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Nuria Vilarrasa
Address:	Feixa Llarga s/n 08907 L´Hospitalet de Llobregat (Barcelona) Spain
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 with a cohort of T2DM (type 2 diabetes mellitus) with insulin treatment before surgery and matched for initial BMI and HbA1c with T1DM group in a proportion 2:1.
Data collected in the questionnaire included the demographic and anthropometric characteristics of the patients and data regarding type 1 and type 2 diabetes (presentation of diabetes onset, diabetes duration before surgery, basal and prandial insulin bolus requirements and changes after surgery, use of subcutaneous insulin infusion (ISCII), presence of diabetes complications and the modifications in the use of lipid-lowering or antihypertensive medications). Laboratory tests including glycosylated hemoglobin (HbA1c) and lipid profile . In T1DM, data on retinal photographs and urinary albumin excretion were evaluated. Moreover, acute diabetic complications after surgery were collected. All data were collected before surgery and annually thereafter.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

PR198/14

Source(s) of Monetary Support

Spanish Society of Endocrinology and Nutrition

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Bellvitge´s Clinical Research and Ethics Commitee from Barcelona, 14/11/2013, ref :PR198/14

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2015
URL:

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