Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT04504968
Brief Summary:
Randomized clinical trial, international, multicentre, single-blind, two parallel groups, pragmatic. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites that will recruit 0-60 participants. Finally, 1050 subjects will be involved in the project.
The primary outcome are the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status
The intervention includes:
Educational program in small groups: 7 sessions in the clinical trial sites (2 sessions a week for the first 3-4 weeks) Exercise program (16 weeks): learning phases in clinical trial site for 3-4 first week (coincident with the educational program sessions) and the rest at home.
Adaptation of targets of HbA1c and blood pressure (BP). UCG Usual care group consists in level of care usually given in Health Care system.
Detailed Description:
International, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5-7 trial sites that will recruit 51 participants (255 participants per country) except Mexico which will select 2 sites to recruit 50 participants each one (100 participants).
There will be a National lead investigator in each involved country. This National lead investigator will be trained by the general coordinator team in the procedures of the study. Each National lead investigator will be responsible for the training in his/her country. In each country, the lead will select the recruitment trial sites (5-7 in each country) and each trial site will recruit 51 participants approximately except in Mexico (see above). All data will be collected in an eCRF (electronic case report form) platform designed specifically for this project.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.
Objectives:
Main objective: To assess the effectiveness of a multi-modal intervention in subjects with type 2 Diabetes Mellitus aged ≥ 65 years who are frail or pre-frail in terms of function and quality of life in comparison with usual clinical practice.
Secondary objectives:
* Changes in the frailty status (trajectories of frailty: frail to prefrail; frail to robustness; prefrail to robustness and vice versa).
* Incidence rate of symptomatic hypoglycemia and hypoglycemic coma.
* Incidence rate of hospital admission.
* Incidence rate of permanent institutionalization.
* Carer burden.
* Laboratory biomarkers of prognostic value for response to treatment
Usual care group:
Usual clinical practice is the level of usual health care that a patient with diabetes receives from their local national health system.
Intervention group:
1. Optimal glycosylated hemoglobin range between 7.6-8.5% (60-69 mmol/mol) and optimal blood pressure: \<150/90 mmHg
2. Physical exercise program that will be used will be the Vivifrail program, developed in Europe (Erasmus + UE). Vivifrail includes:
* Strength exercises for arms and legs.
* Balance and gait, to avoid falls.
* Flexibility.
* Resistance. The duration of the training program will be 16 weeks.
3. Nutritional and educational program: The intervention is designed to increase diabetes knowledge, develop practical self-care skills for diabetes, and increase the likelihood of improving glycemic control safely. The intervention aims to minimize the risk of hypoglycemia, ensure optimal nutritional status, and help maintain functional status.
Study:
NCT04504968
Study Brief:
Protocol Section:
NCT04504968