NCT02934737

Brief Summary

Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will be observed (if any). Anthropometric and biochemical parameters will be evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

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

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

October 12, 2016

Last Update Submit

November 8, 2020

Conditions

Obese Patients

Keywords

ObesityDiabetes Mellitus

Outcome Measures

Primary Outcomes (5)

  • Progression of diabetes

    evaluation of glycemia during 8 years

    8 years

  • Anthropometric parameters

    Weight

    8 years

  • Anthropometric parameters

    Waist circumference; hip circumference; abdominal circumference

    8 years

  • Markers of progression of diabetes

    Adiponectin

    8 years

  • Markers of progression of diabetes

    Resistin

    8 years

Interventions

Progression of diabetesOTHER
Also known as: Variations of biochemical parameters

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Output patients with obesity

You may qualify if:

  • Obesity (body mass index \>/= 30 Kg/m2
  • Normal blood glucose (glycemia \< 100 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Giuseppe Derosa, MD, PhD, FESC

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share