Progressive Weight Loss and Metabolic Health (PWL)
30 juni 2017 uppdaterad av: Washington University School of Medicine
This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%) weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.
Participants will be randomly assigned to one of 2 groups.
Group 1: supervised weight loss group (low-calorie diet).
Group 2: supervised weight maintenance group (normal diet).
Of those assigned to group 1, half of the participants will lose 5% of their body weight and the other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a dietitian.
Research testing will be repeated at each time point (5%, 10%, and 15% weight loss).
In group 2, research testing will be repeated after six months.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
59
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Obese: Body Mass Index from 30 to 45
- Insulin Resistant: HOMA-IR score greater than or equal to 2
Exclusion Criteria:
- diabetes
- smoking
- pregnancy
- breastfeeding
- heart failure
- history of liver disease including hepatitis
- alcoholism
- exercise more than 2 hours per week
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Weight Loss
Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
|
Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
|
|
Aktiv komparator: Weight Maintenance
Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.
|
Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insulin Sensitivity
Tidsram: baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure insulin sensitivity at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure insulin sensitivity at baseline and after six months.
|
baseline through weight loss (approximately one year)
|
|
intra-hepatic triglyceride
Tidsram: baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure intra-hepatic triglyceride at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure intra-hepatic triglyceride at baseline and after six months.
|
baseline through weight loss (approximately one year)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
total cholesterol
Tidsram: baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure total cholesterol at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure total cholesterol at baseline and after six months.
|
baseline through weight loss (approximately one year)
|
|
systolic blood pressure
Tidsram: baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure systolic blood pressure at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure systolic blood pressure at baseline and after six months.
|
baseline through weight loss (approximately one year)
|
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Cell proliferation (growth) rates in the colon - optional procedure
Tidsram: baseline through weight loss (approximately four months to one year)
|
Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples.
In the weight-loss arm we will measure colonocyte proliferation rate at baseline, and once again after weight loss (either 5% weight loss, or 10% weight loss, or 15% weight loss; i.e.
only one time after weight loss).
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure colonocyte proliferation rate at baseline and after six months.
|
baseline through weight loss (approximately four months to one year)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.
- Volkow ND, Wang GJ, Telang F, Fowler JS, Goldstein RZ, Alia-Klein N, Logan J, Wong C, Thanos PK, Ma Y, Pradhan K. Inverse association between BMI and prefrontal metabolic activity in healthy adults. Obesity (Silver Spring). 2009 Jan;17(1):60-5. doi: 10.1038/oby.2008.469. Epub 2008 Oct 23.
- van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10.
- de Jonge L, Moreira EA, Martin CK, Ravussin E; Pennington CALERIE Team. Impact of 6-month caloric restriction on autonomic nervous system activity in healthy, overweight, individuals. Obesity (Silver Spring). 2010 Feb;18(2):414-6. doi: 10.1038/oby.2009.408. Epub 2009 Nov 12.
- McLaughlin T, Abbasi F, Kim HS, Lamendola C, Schaaf P, Reaven G. Relationship between insulin resistance, weight loss, and coronary heart disease risk in healthy, obese women. Metabolism. 2001 Jul;50(7):795-800. doi: 10.1053/meta.2001.24210.
- Chondronikola M, Magkos F, Yoshino J, Okunade AL, Patterson BW, Muehlbauer MJ, Newgard CB, Klein S. Effect of Progressive Weight Loss on Lactate Metabolism: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):683-688. doi: 10.1002/oby.22129. Epub 2018 Feb 24.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2011
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 april 2016
Studieregistreringsdatum
Först inskickad
10 februari 2011
Först inskickad som uppfyllde QC-kriterierna
17 februari 2011
Första postat (Uppskatta)
18 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201012904
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