免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome

Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome

Study Description
Brief Summary:
Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Dyslipidemias Other: Carbohydrate restricted group Other: Standard low fat diet Not Applicable

Detailed Description:
Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Carbohydrate restricted group
This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.
 Other: Carbohydrate restricted group
Prescribed low carbohydrate diet with set recipes
Active Comparator: Standard/Low fat diet group
The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.
 Other: Standard low fat diet
Diet with less than 20% total calorie intake from dietary fats
Outcome Measures
Primary Outcome Measures :
  1. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum High density Lipoprotein level in mg/dL

  2. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum High density Lipoprotein in mg/dL

  3. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum Triglyceride level in mg/dL

  4. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum Triglyceride level in mg/dL

  5. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle number

  6. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle number

  7. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle concentration

  8. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle concentration

  9. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum high density lipoprotein particle

  10. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum high density lipoprotein particle

  11. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein particle

  12. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein particle

  13. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein size

  14. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein size


Secondary Outcome Measures :
  1. Insulin resistance indices [ Time Frame: Baseline ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  2. Insulin resistance indices [ Time Frame: Baseline to 8 weeks ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  3. Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition

  4. Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition

  5. Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content

  6. Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content

  7. Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in flow mediated dilation

  8. Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in flow mediated dilation

  9. Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in Pulse wave velocity

  10. Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in Pulse wave velocity

  11. Surrogate markers of vascular endothelial function as measured by Augmentation index [ Time Frame: Baseline ]
    The Augmentation Index a measure of peripheral arterial stiffness

  12. Surrogate markers of vascular endothelial function as measured by Augmentation index [ Time Frame: Baseline to 8 weeks ]
    The Augmentation Index a measure of peripheral arterial stiffness


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 3 out of 5 of the following criteria

  • Metabolic syndrome with dyslipidemia
  • (HDL <40mg/dL
  • Triglyceride (TG) TG>150mg/dL)
  • Glucose intolerance (fasting blood sugar >100mg/dL)
  • Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower)
  • Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension

Exclusion Criteria:

  • Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants)
  • Pregnancy
  • Untreated thyroid disease, heart disease, cancer, kidney disease
  • Children on statin/fibrate treatments or other lipid-lowering medications
  • Prior surgical procedure for weight control or current weight loss medication
Contacts and Locations

Contacts
Layout table for location contacts
Contact: BHUVANA SUNIL, MD 2056386456 bsunil@uabmc.edu

Locations
Layout table for location information
United States, Alabama
Bhuvana Sunil Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Bhuvana Sunil    205-638-6456    bsunil@uabmc.edu   
Principal Investigator: BHUVANA Sunil, MD         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: BHUVANA SUNIL, MD    205-638-9107    bsunil@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Bhuvana Sunil, MD University of Alabama at Birmingham
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum High density Lipoprotein level in mg/dL
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum High density Lipoprotein in mg/dL
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum Triglyceride level in mg/dL
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum Triglyceride level in mg/dL
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle number
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle number
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle concentration
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle concentration
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum high density lipoprotein particle
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum high density lipoprotein particle
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein particle
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein particle
  • Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein size
  • Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein size
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • Insulin resistance indices [ Time Frame: Baseline ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
  • Insulin resistance indices [ Time Frame: Baseline to 8 weeks ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
  • Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition
  • Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition
  • Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content
  • Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in flow mediated dilation
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in flow mediated dilation
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in Pulse wave velocity
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in Pulse wave velocity
  • Surrogate markers of vascular endothelial function as measured by Augmentation index [ Time Frame: Baseline ]
    The Augmentation Index a measure of peripheral arterial stiffness
  • Surrogate markers of vascular endothelial function as measured by Augmentation index [ Time Frame: Baseline to 8 weeks ]
    The Augmentation Index a measure of peripheral arterial stiffness
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Insulin resistance indices [ Time Frame: Baseline ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
  • Insulin resistance indices [ Time Frame: Baseline to 8 weeks ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
  • Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition
  • Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition
  • Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content
  • Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in flow mediated dialtion
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in flow mediated dialtion
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in Pulse wave velocity
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in Pulse wave velocity
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in Augmentation Index
  • Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in Augmentation Index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Official Title  ICMJE Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
Brief Summary Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.
Detailed Description Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
  • Dyslipidemias
Intervention  ICMJE
  • Other: Carbohydrate restricted group
    Prescribed low carbohydrate diet with set recipes
  • Other: Standard low fat diet
    Diet with less than 20% total calorie intake from dietary fats
Study Arms  ICMJE
  • Active Comparator: Carbohydrate restricted group
    This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.
    Intervention: Other: Carbohydrate restricted group
  • Active Comparator: Standard/Low fat diet group
    The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.
    Intervention: Other: Standard low fat diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: 3 out of 5 of the following criteria

  • Metabolic syndrome with dyslipidemia
  • (HDL <40mg/dL
  • Triglyceride (TG) TG>150mg/dL)
  • Glucose intolerance (fasting blood sugar >100mg/dL)
  • Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower)
  • Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension

Exclusion Criteria:

  • Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants)
  • Pregnancy
  • Untreated thyroid disease, heart disease, cancer, kidney disease
  • Children on statin/fibrate treatments or other lipid-lowering medications
  • Prior surgical procedure for weight control or current weight loss medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BHUVANA SUNIL, MD 2056386456 bsunil@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937960
Other Study ID Numbers  ICMJE IRB-300002816
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bhuvana Sunil, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bhuvana Sunil, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯