Ignite Creation Date:
2024-05-06 @ 7:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02452567
Status:
WITHDRAWN
Last Update Posted:
2021-05-28
First Post:
2015-04-15
Brief Title:
Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting participants that met the inclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAL
Brief 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 185-249 kgm² 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 56 glycated hemoglobin 57 fasting plasma glucose concentration 100 mgdl 2-hr oral glucose tolerance test OGTT plasma glucose concentration 140 mgdl homeostatic model assessment of insulin resistance HOMA-IR 25 men and women Only lean people who have a BMI 210 but 250 kgm² will be asked to lose weight to avoid the risk that participants become underweight BMI 185 kgm² during weight loss therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None