Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/12/2018 |
| Start Date: | May 2015 |
| End Date: | September 2019 |
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.
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.
Inclusion Criteria:
- BMI 21.0-24.9 kg/m²
- Weight stable (+/- 2% for at least 3 months before enrollment)
- Two or more of the following: IHTG content ≥5.6%, HOMA- IR index ≥ 2.5, HbA1C ≥ 5.7%,
2-hr OGTT plasma glucose concentration ≥ 140 mg/dl, fasting plasma glucose
concentration ≥ 100 mg/dl.
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Evidence of significant organ system dysfunction or disease (e.g., diabetes, chronic
kidney disease, advanced heart disease, etc.)
- Men who consume >21 units (e.g., glass of wine or bottle of beer) of alcohol per week
and women who consume >14 units of alcohol per week
- Use of dietary supplements or medications known to affect metabolism
- Eating disorder (assessed by using the Eating Disorder Examination Questionnaire
[EDE-Q])
- Participation in structured endurance or resistance exercise program >150 min/week
- Use of tobacco products
- Unable or unwilling to follow the study protocol or the research team believes that
for any reason the volunteer is not an appropriate candidate for this study, including
non-compliance with screening appointments or previous appointments/contact
arrangements
- Individuals that take Coumadin or similar anticoagulants
- Use of antibiotics in last 60 days
- Previous bariatric surgery
- Cancer or cancer that has been in remission for <5 years
- Major psychiatric illness
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Samuel Klein, MD
Phone: 314-362-4375
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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