Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Type 2 Diabetes MellitusContinous Glucose MonitoringCognitionMetforminGut microbiomeMagnetic resonance imagingPhysical activity monitor

Outcome Measures

Primary Outcomes (17)

Gut microbiota composition.
It will be identified in the stool by cultures and DNA and mRNA expression after metformin treatment.
12 months
Cognitive impairment
It will be measured by Mini-Examen Cognoscitivo (MEC).
12 months
Audioverbal memory
It will be measured by Test aprendizaje verbal-TAVEC.
12 months
Visual memory
It will be measured by Rey-Osterrieth Complex Figure.
12 months

Secondary Outcomes (6)

The percentage of time in glucose target range (glucose level 70mg/dl-180mg/dl)
12 months
Effect on gut microbiota
12 months
The percentage of time in glucose range (glucose level below 100 mg/dl)
12 months
The percentage of time in glucose range (glucose level between 100-125 mg/dl)
12 months
The percentage of time in glucose range (glucose level between 126-139 mg/dl)
12 months
+1 more secondary outcomes

Other Outcomes (28)

Integrity of the brain gray matter
12 months
Integrity of the white matter tracts
12 months
Brain iron accumulation
12 months
+25 more other outcomes

Study Arms (2)

Patients with recently diagnosed T2DM

This group will consist of 36 recently diagnosed T2DM, according to the World Health Organization (WHO) patients (last 6 months), who have not received treatment with metformin.

Drug: Metformin

Patients with long-term T2DM

The group will consist of 100 patients with long-term T2DM, according to the WHO classification, regardless of whether they take metformin or another treatment.

Interventions

MetforminDrug

Patients will begin treatment with metformin administered orally at a starting dose of 425 mg / day every 12 hours for the first 15 days and then continue with a dose of 850 mg / day until the end of the study. The beginning of this treatment phase will be following the recommendations of the clinical guidelines (Comprehensive Approach to Type 2 Diabetes Mellitus, SEEN V2019.2)

Patients with recently diagnosed T2DM

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age65 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Group A Study population Adult patients (≥ 65 years of age) recently diagnosed with T2DM according to the WHO and who have not been treated with metformin. Group B Study population Adult patients (≥ 65 years of age) diagnosed with long-term T2DM according to the WHO classification, regardless of whether they take metformin or other treatment.

You may qualify if:

Age between 55 and 80 years.

Sponsors & Collaborators

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Otherlead

Study Sites (1)

Institut d'Investigació Biomèdica de Girona (IDIBGI)

Girona, Girona, 17007, Spain

Related Publications (53)

Fama R, Sullivan EV. Thalamic structures and associated cognitive functions: Relations with age and aging. Neurosci Biobehav Rev. 2015 Jul;54:29-37. doi: 10.1016/j.neubiorev.2015.03.008. Epub 2015 Apr 9.
PMID: 25862940BACKGROUND
Williams KN, Kemper S. Interventions to reduce cognitive decline in aging. J Psychosoc Nurs Ment Health Serv. 2010 May;48(5):42-51. doi: 10.3928/02793695-20100331-03.
PMID: 20415290BACKGROUND
Aigbogun MS, Stellhorn R, Krasa H, Kostic D. Severity of memory impairment in the elderly: Association with health care resource use and functional limitations in the United States. Alzheimers Dement (Amst). 2017 Apr 20;8:51-59. doi: 10.1016/j.dadm.2017.04.001. eCollection 2017.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

José M Fernández-Real, Ph.D.
Institut d'Investigació Biomèdica de Girona (IDIBGI)
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal investigator, clinical professor, section chief of Endocrinology and Nutrition Department of Josep Trueta University Hospital

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 12, 2021

Study Start

April 10, 2021

Actual (reported)

Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (17)

Secondary Outcomes (6)

Other Outcomes (28)

Study Arms (2)

Patients with recently diagnosed T2DM

Patients with long-term T2DM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (53)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (17)

Secondary Outcomes (6)

Other Outcomes (28)

Study Arms (2)

Patients with recently diagnosed T2DM

Patients with long-term T2DM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (53)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations