NCT04484883

Brief Summary

The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

July 21, 2020

Last Update Submit

July 24, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

  • Body weight

    Body weight in Kilograms

    Baseline

  • Neck circumference

    Neck circumference in cm

    Baseline

  • Waist circumference

    Waist circumference in cm

    At baseline

  • Hip circumference

    Hip circumference in cm

    Baseline

  • Body mass index (BMI)

    Body mass index (BMI) (expressed in kg/m\^2)

    At baseline

  • Resting Energy Expenditure (REE)

    Resting Energy Expenditure (REE) in kcal

    At baseline

Interventions

ObservationalOTHER

Observational

Also known as: Retrospective cohort study

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)

You may qualify if:

  • Patients with type 2 diabetes
  • Available resting energy expenditure assessed by indirect calorimetry

You may not qualify if:

  • data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved
  • presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR \< 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

June 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)