Plain English Summary
Background and study aims
Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. The aim of this study is to find out whether autoantibodies currently thought to predict autoimmunity (an immune response of the body against its own healthy tissues) are present in type 2 diabetes patients.
Who can participate?
Patients with type 2 diabetes with onset over 65 years of age and a BMI under 30 kg/m2
What does the study involve?
Participants undergo height, weight, waist and blood pressure measurements. After a 12-h overnight fast, blood samples are taken to test for autoantibodies.
What are the possible benefits and risks of participating?
The study may lead to better treatment of type 2 diabetes. The study has no risks for the patients.
Where is the study run from?
1. Hospital Sirio Libanés (Argentina)
2. Buenos Aires University (Argentina)
When is the study starting and how long is it expected to run for?
March 2012 to February 2018
Who is funding the study?
University Institute of Health Sciences, Barcelo Foundation (Argentina)
Who is the main contact?
Prof. Gustavo Frechtel
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12446980
Study information
Scientific title
Immunological and clinical characteristics of Latent Autoimmune Diabetes in the Elderly (LADE)
Acronym
LADE
Study hypothesis
Autoantibodies currently regarded to have predictive value for autoimmunity are present in T2DM patients with onset over 65 years of age and a BMI under 30 kg/m2.
Ethics approval
Ethics Committee Hospital de Clínicas Universidad de Buenos Aires, 06/08/2012, ref: 12446980
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Autoimmune and non autoimmune type 2 diabetes mellitus
Intervention
155 T2DM patients were randomly recruited between June 2014 and March 2017 with two principal inclusion criteria: individuals with diabetes onset over 65 years of age and a BMI under 30 kg/m2.
Anthropometric measurements (height, weight and waist circumference), systolic blood pressure and diastolic blood pressure were determined by standardized protocols. BMI was calculated as weight (kg)/[height(m)]2. After a 12-h overnight fast, venous blood samples were obtained from every individual, centrifuged to obtain serum and analyzed immediately. Fasting plasma glucose (FPG), creatinine, total cholesterol, TG, LDL-C and HDL-C were determined in serum using standardized procedures by enzymatic methods. HbA1c was measured using high-performance liquid chromatography (HPLC) Variant II Turbo HbA1c Kit 2.0. GADA, IA2A and ZnT8A were assessed by radio ligand binding assay (RBA) as described.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The prevalence of the autoantibodies GADA, IA2A and ZnT8A, assessed by radio ligand binding assay (RBA) at a single study visit
Secondary outcome measures
Measured at a single study visit:
1. HbA1c, measured using high-performance liquid chromatography (HPLC) Variant II Turbo HbA1c Kit 2.0
2. Cardiovascular disease prevalence, assessed using patients clinical records of coronary heart disease, stroke, or peripheral arterial disease
3. Fasting plasma glucose (FPG), creatinine, total cholesterol, TG, LDL-C and HDL-C, measured in serum using standardized procedures by enzymatic methods
4. BMI, calculated as weight (kg)/[height(m)]2
5. Anthropometric measurements (height, weight and waist circumference), systolic blood pressure and diastolic blood pressure, determined by standardized protocols
Overall trial start date
30/03/2012
Overall trial end date
15/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. T2DM patients
2. Diabetes onset over 65 years of age
3. BMI under 30 kg/m2
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
155
Participant exclusion criteria
1. Patients with active systemic disorders and/or infections
2. Individuals with a previous diagnosis of T1DM, liver or heart failure
3. Surgery or hospitalization over the past year
Recruitment start date
01/06/2014
Recruitment end date
01/03/2017
Locations
Countries of recruitment
Argentina
Trial participating centre
Hospital Sirio Libanés
Buenos Aires
1419
Trial participating centre
Buenos Aires University
School of Pharmacy and Biochemistry
1413
Trial participating centre
Buenos Aires University
Institute of Immunology, Genetics and Metabolism
Clinical Hospital and School of Pharmacy and Biochemistry
1413
Sponsor information
Organisation
Sirio Libanés Hospital
Sponsor details
Campana 4658
Buenos Aires
1419
Argentina
+54 (0)114574-4343
residencias@hospitalsiriolibanes.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University Institute of Health Sciences, Barcelo Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists are planning a publication in a high-impact peer reviewed journal in the near future.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Gustavo Frechtel.
Intention to publish date
08/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list