Weight LossMALNCT02452567
Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects
A study testing Moderate (8-10%) diet-induced weight loss in people with Weight Loss, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Moderate (8-10%) diet-induced weight loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Weight Loss
- Being tested
- Moderate (8-10%) diet-induced weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate (8-10%) diet-induced weight lossOther
MAL participants will meet with the study dietitian to lose ~8-10% of their body weight through diet-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Metabolically abnormal lean | Experimental | Moderate (8-10%) diet-induced weight loss. Receives: Other: Moderate (8-10%) diet-induced weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity as assessed by the hyperinsulinemic-euglycemic clamp technique
Evaluate insulin sensitivity through the hyperinsulinemic-euglycemic clamp procedure.
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Secondary outcomes (7)
Change in Beta-Cell function
Administer 3 hour oral glucose tolerance test before and after weight loss to determine the effects of weight loss on beta cell function
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in fat mass and fat free mass as assessed by dual-energy x-ray absorptiometry (DXA)
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in intra-abdominal adipose tissue volume as assessed by magnetic resonance imagining.
Inta-abdominal adipose tissue volume will be assessed before and after weight loss to determine the effects of weight loss
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Blood will be drawn for the complete metabolic panel and lipid panel before and after weight loss
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in markers of inflammation in plasma and adipose tissue as assessed from samples obtained during the hyperinsulinemic-euglycemic clamp procedure with adipose tissue biopsies
Plasma samples and adipose tissue biopsies will be obtained during the hyperinsulinemic-euglycemic clamp procedure before and after weight loss
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in cellular factors involved in mediating insulin action in muscle and adipose tissue as assessed by muscle and adipose tissue biopsies obtained during the hyperinsulinemic-euglycemic clamp procedure
Muscle and adipose tissue biopsy samples will be obtained during the hyperinsulinemic-euglycemic clamp procedure before and after weight loss
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Modification of gut microbiota
Monthly stool collection will be used to assess the composition of the gut microbiota, meta-transcriptome (bacterial RNA sequencing to determine what proteins can be made by the microbiota), and the meta-metabolome (metabolites made by the microbiota).
Measured: An average of 6-8 months from baseline testing to 8-10% weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2021
- Study completionMay 2021
Why it stopped: Difficulty recruiting participants that met the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452567
- Sponsor's protocol ID
- 201501010
- Acronym
- MAL
- Status last verified
- May 2021
- First submitted
- 15 Apr 2015
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate Weight Loss in Metabolically Abnormal Lean Subjects
- ClinicalTrials.gov ID
- NCT02452567
- Acronym / sponsor ID
- MAL / 201501010
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting participants that met the inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolically abnormal lean | Experimental | Other: Moderate (8-10%) diet-induced weight lossModerate (8-10%) diet-induced weight loss. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate (8-10%) diet-induced weight lossMAL participants will meet with the study dietitian to lose ~8-10% of their body weight through diet-intervention. | Other | Metabolically abnormal lean |
Primary outcome
Change in insulin sensitivity as assessed by the hyperinsulinemic-euglycemic clamp technique
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Evaluate insulin sensitivity through the hyperinsulinemic-euglycemic clamp procedure.
7 secondary outcomes
Change in Beta-Cell function
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in fat mass and fat free mass as assessed by dual-energy x-ray absorptiometry (DXA)
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in intra-abdominal adipose tissue volume as assessed by magnetic resonance imagining.
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in markers of inflammation in plasma and adipose tissue as assessed from samples obtained during the hyperinsulinemic-euglycemic clamp procedure with adipose tissue biopsies
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Change in cellular factors involved in mediating insulin action in muscle and adipose tissue as assessed by muscle and adipose tissue biopsies obtained during the hyperinsulinemic-euglycemic clamp procedure
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Modification of gut microbiota
Time frame: An average of 6-8 months from baseline testing to 8-10% weight loss
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate (8-10%) diet-induced weight loss in people with Weight Loss, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity as assessed by the hyperinsulinemic-euglycemic clamp technique (time frame: An average of 6-8 months from baseline testing to 8-10% weight loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.