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Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects

NCT02452567 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-28

No results posted yet for this study

Summary

Obesity is associated with a constellation of cardiometabolic abnormalities (including insulin resistance, elevated blood pressure and dyslipidemia) that are risk factors for diabetes and cardiovascular disease. Weight loss can improve all of the cardiometabolic abnormalities associated with obesity. Up to \~25% of lean people (Body Mass Index \[BMI\] 18.5-24.9 kg/m²) have many of the cardiometabolic abnormalities associated with obesity and are referred to as metabolically abnormal lean (MAL) people. However, the MAL phenotype is not well characterized, and it is unclear whether weight loss has beneficial metabolic effects in already lean people. Accordingly, the goal of this study is to: 1) carefully phenotype MAL people and 2) evaluate the effect of moderate (8-10%) diet-induced weight loss in MAL people. This will be investigated in 15 MAL (defined as having 2 or more of the following: intrahepatic triglyceride (IHTG) content ≥5.6%, glycated hemoglobin ≥5.7%, fasting plasma glucose concentration ≥100 mg/dl, 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl, homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 2.5) men and women. Only lean people who have a BMI ≥21.0 but \<25.0 kg/m² will be asked to lose weight to avoid the risk that participants become underweight (BMI \<18.5 kg/m²) during weight loss therapy.

Conditions

Interventions

OTHER

Moderate (8-10%) diet-induced weight loss

MAL participants will meet with the study dietitian to lose \~8-10% of their body weight through diet-intervention.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452567 on ClinicalTrials.gov