Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/04/2018
Date assigned
25/05/2018
Last edited
08/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Gustavo Frechtel

ORCID ID

Contact details

Córdoba 2351
Buenos Aires City
1413
Argentina

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

Publication citations

Additional files

Editorial Notes