NCT05714852

Brief Summary

Intervention designed to promote healthy eating in patients with type 2 diabetes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

May 16, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 26, 2023

Last Update Submit

May 15, 2023

Conditions

Healthy LifestyleDiabetes

Outcome Measures

Primary Outcomes (2)

  • Change in plasma triglycerides

    Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform

    Before - 16 weeks

  • Change in blood glucose

    Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform

    Before - 16 weeks

Secondary Outcomes (1)

  • Change in waist circumference

    Before - 16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Healthy eating

Control

NO INTERVENTION

Interventions

Healthy eatingBEHAVIORAL

Promotion of healthy eating

Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age
  • Type 2 diabetes
  • Poor dietary habits

You may not qualify if:

  • Micro and macro-vascular complications
  • Poor glycemic control
  • Food allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Antonio Cano

CONTACT

0034 629308479antonio.cano@uv.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

February 15, 2023

Primary Completion

February 10, 2025

Study Completion

February 10, 2026

Last Updated

May 16, 2023

Record last verified: 2023-01

Locations

ES(1)