NCT03221322

Brief Summary

Obesity is the 5th leading cause of global death, and is major risk factors for many chronic diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. Obesity is caused by an imbalance between energy intake and energy expenditure, and it is widely agreed to be a consequence of a gene by environment interaction. Although on average obesity rates are increasing, the shape of the distribution of adiposity is changing: it is becoming more right skewed. This is because there is a population of very lean subjects that has remained almost unchanged by the epidemic. The investigators have called these very lean individuals that are resistant to the epidemic and sustain a BMI \< 18.5 kg/m2 'super lean' subjects. We have very little understanding of the lifestyles of these individuals and how they are able to maintain their super lean phenotype, and whether the basis of their leanness is primarily genetics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 6, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

8.7 years

First QC Date

June 27, 2017

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Anthropometric measurements of participants in both control and superlean groups

    Height, waist and hip circumferences (cm) and body composition will be measured on arrival.

    Through study completion, an average of 2 years

  • Demographic characteristics of all participants in both control and superlean groups

    Life style questionnaire filled out on arrival.

    Through study completion, an average of 2 years

Study Arms (2)

Control

20 kg/m2 ≤ BMI ≤ 25 kg/m2, healthy, with no eating disorder, 150 subjects, 20 - 40 years old

Behavioral: Superlean

Superlean

15 kg/m2 ≤ BMI ≤ 18 kg/m2, healthy, with no eating disorder, 150 subjects, 25 - 35 years old in particular

Behavioral: Superlean

Interventions

SuperleanBEHAVIORAL

Behavioural data will be collected on all subjects in either control group or superlean group. Blood or saliva samples will be collected for DNA extraction and genotyping.

ControlSuperlean

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants are healthy, with no eating disorder, 25 - 35 years old in particular.

You may qualify if:

  • control: BMI 20-25 kg/m2, healthy, age 20-40 years old superlean: BMI 15-18 kg/m2, healthy, with no eating disorders and diabetes, age 20-40 years old

You may not qualify if:

  • Pregnant women and women in lactation Subjects are suffering from eating disorders or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Genetics and Developmental Biology

Beijing, 100101, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

9 ml of blood samples will be collected for the biological measurements and DNA extraction for genotyping.

MeSH Terms

Conditions

ThinnessHealth Behavior

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • John Speakman, PhD

    Institute of Genetics and Developmental Biology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Speakman, PhD

CONTACT

Sumei Hu, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 18, 2017

Study Start

April 6, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations