Latent autoimmune diabetes in the elderly
| ISRCTN | ISRCTN99959577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99959577 |
| Secondary identifying numbers | 12446980 |
- Submission date
- 16/04/2018
- Registration date
- 25/05/2018
- Last edited
- 08/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Córdoba 2351
Buenos Aires City
1413
Argentina
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Immunological and clinical characteristics of Latent Autoimmune Diabetes in the Elderly (LADE) |
| Study acronym | LADE |
| Study objectives | 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(s) | Ethics Committee Hospital de Clínicas Universidad de Buenos Aires, 06/08/2012, ref: 12446980 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 30/03/2012 |
| Completion date | 15/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 155 |
| Key inclusion criteria | 1. T2DM patients 2. Diabetes onset over 65 years of age 3. BMI under 30 kg/m2 |
| Key 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 |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- Argentina
Study participating centres
1419
1413
Clinical Hospital and School of Pharmacy and Biochemistry
1413
Sponsor information
Hospital/treatment centre
Campana 4658
Buenos Aires
1419
Argentina
| Phone | +54 (0)114574-4343 |
|---|---|
| residencias@hospitalsiriolibanes.org |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 08/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists are planning a publication in a high-impact peer reviewed journal in the near future. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Gustavo Frechtel. |
