Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/04/2016
Date assigned
12/04/2016
Last edited
11/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a condition that causes a person’s blood sugar level to become too high. Insulin is the hormone made by beta-cells in the pancreas and controls the amount of glucose in the blood. Type 1 diabetes occurs when the pancreas does not produce any insulin. Type 2 diabetes occurs when the pancreas does not produce enough insulin or the person’s cells do not react to insulin. In recent years, the number of patients with type 1 diabetes that are also obese (very overweight) has increased, affecting around 28% of adults and children with type 1 diabetes. The effect of weight loss (bariatric) surgery on type 1 diabetes have only been investigated in small groups of people over a short period of time. Most of the studies that have taken place show that the patients lost weight and didn’t have to take so much insulin. They also become less at risk of developing cardiovascular (for example, heart) disease and had improved blood sugar and cholesterol levels in the short term. This study investigates what the long-term effects of bariatric surgery are on obese type 1 diabetics, focussing on blood sugar control, blood pressure and cholesterol levels over time and possible diabetic complications, such as kidney and eye damage. The results are then compared to those taken from a group of obese patients with type 2 diabetes that have also had bariatric surgery.

Who can participate?
Patients with type 1 or 2 diabetes that have undergone bariatric surgery as a treatment for obesity.

What does the study involve?
Health data for type 1 diabetes patients that have had bariatric surgery as a treatment for obesity are compared against type 2 diabetes patients that have had the same procedure. Detailed clinical and biochemical data is collected from medical charts. Information on how long the patient has had diabetes, their insulin requirements and how this changes after the surgery and whether they develop any complications as a result of their diabetes are all assessed, as well laboratory tests to check for metabolic control changes and body fat (lipid profile) changes.

What are the possible benefits and risks of participating?
Participants in the study will benefit from a closer follow-up by the research team. No health risks will be associated with the participation in the study.

Where is the study run from?
A total of eight hospitals in Spain

When is the study starting and how long is it expected to run for?
December 2013 to December 2015

Who is funding the study?
Spanish Society of Endocrinology and Nutrition

Who is the main contact?
1. Dr Nuria Vilarrasa (scientific)
2. Dr Miguel Angel Rubio (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nuria Vilarrasa

ORCID ID

http://orcid.org/0000-0003-3188-1990

Contact details

Feixa Llarga s/n
L´Hospitalet de Llobregat (Barcelona)
08907
Spain

Type

Scientific

Additional contact

Dr Miguel Angel Rubio

ORCID ID

Contact details

Martín Lagos s/n
Madrid
28040
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR198/14

Study information

Scientific title

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

Acronym

Study hypothesis

Bariatric surgery in T1DM (type 1 diabetes mellitus) provides the benefits of weight reduction on insulin requirements, obesity comorbidities, and some benefits in diabetes complications, but has no effect on the metabolic control in the long-term.

Ethics approval

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

Study design

Multicenter, retrospective observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

1. Morbid obesity
2. Type 1 and type 2 diabetes mellitus

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/12/2013

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 in type 1 diabetes group and 60 in type 2 diabetes group

Participant 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

Recruitment start date

01/12/2013

Recruitment end date

01/12/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Bellvitge´s University Hospital
Feixa LLarga s/n
Barcelona
08907
Spain

Trial participating centre

Hospital Clínico San Carlos. IDISSC.
Martín Lagos s/n
Madrid
28040
Spain

Trial participating centre

Sabadell University Hospital (UAB)
Corporació Sanitària Parc Taulí c/ Parc Taulí nº 1
Sabadell
08208
Spain

Trial participating centre

Hospital de la Santa Creu i Sant Pau
C/Sant Antoni Maria Claret 167
Barcelona
08025
Spain

Trial participating centre

Hospital Vall d´Hebron
Passeig Vall d'Hebron, 119-129
Barcelona
08035
Spain

Trial participating centre

Hospital Universitario Virgen del Rocío
Avenida Manuel Siurot s/n
Sevilla, Spain
41013
Spain

Trial participating centre

Hospital Universitari Arnau de Vilanova
Avda. Rovira Roure 80
25198 Lleida
25198
Spain

Trial participating centre

Hospital Clinic Universitari
c/ Villaroel 170
Barcelona
08036
Spain

Sponsor information

Organisation

Spanish Society of Endocrinology and Nutrition (SEEN)

Sponsor details

c/Villalar 7 bajo-interior derecha
Madrid
28001
Spain
914313294
secretaria@seen.es

Sponsor type

Research organisation

Website

www.seen.es

Funders

Funder type

Research organisation

Funder name

Spanish Society of Endocrinology and Nutrition

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in peer reviewed scientific journals.

Intention to publish date

01/05/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes