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Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial (ADEPT)

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ClinicalTrials.gov Identifier: NCT03675360
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Kirsten Dorans, Tulane University School of Public Health and Tropical Medicine

Brief Summary:
The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes PreDiabetes Metabolic Disease Hyperglycemia Diet Modification Glucose Intolerance Glucose Metabolism Disorders (Including Diabetes Mellitus) Endocrine System Diseases Behavioral: Low-Carbohydrate Diet Not Applicable

Detailed Description:

In the short-term, among patients with type 2 diabetes, low-to-moderate carbohydrate diets have a greater glucose-lowering effect than do high-carbohydrate diets. However, compared with usual diet, the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern among individuals with prediabetes or untreated type 2 diabetes is not well understood.

The overall goal of this randomized controlled trial is to study the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern compared with usual diet on hemoglobin A1c (HbA1c) and other metabolic risk factors among individuals with or at high risk of diabetes (HbA1c 6.0-6.9%).

A total of 112 participants with HbA1c 6.0-6.9% will be recruited and randomly assigned to either a 6-month behavioral modification program designed to reduce carbohydrate intake (initial target <40 g digestible carbohydrates, final target <60 g digestible carbohydrates) or to usual diet in a 1:1 randomization ratio.

The primary outcome will be the difference between the active intervention and control groups for change in HbA1c from baseline to 6 months. Secondary outcomes will be fasting glucose, systolic blood pressure, total-to-high-density lipoprotein-cholesterol ratio, and body weight.

Findings from this study may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Low-Carbohydrate Diet

Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.

At baseline, participants will receive written information with standard physical activity recommendations.

Behavioral: Low-Carbohydrate Diet

Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.

At baseline, participants will receive written information with standard physical activity recommendations.


No Intervention: Usual Diet

No dietary intervention.

At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.




Primary Outcome Measures :
  1. Change in Hemoglobin A1c [ Time Frame: Baseline and six months ]

Secondary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: Baseline and six months ]
  2. Change in systolic blood pressure [ Time Frame: Baseline and six months ]
  3. Change in total-to-HDL-cholesterol ratio [ Time Frame: Baseline and six months ]
  4. Change in body weight [ Time Frame: Baseline and six months ]

Other Outcome Measures:
  1. Change in insulin [ Time Frame: Baseline and six months ]
  2. Change in homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Baseline and six months ]
  3. Change in diastolic blood pressure [ Time Frame: Baseline and six months ]
  4. Change in waist circumference [ Time Frame: Baseline and six months ]
  5. Change in estimated cardiovascular disease risk [ Time Frame: Baseline and six months ]
    Based on 10-year cardiovascular disease risk assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women ages 40 to 70 years
  • HbA1c 6.0-6.9%
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Diagnosed type 1 diabetes mellitus
  • Use of agents affecting glycemic control (medications for diabetes, oral glucocorticoids) within the past three months prior to enrollment
  • Medical condition in which low-carbohydrate diet may not be advised: estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m²; self-report of liver disease due to hepatitis or alcohol; osteoporosis; untreated thyroid disease; gout; cancer (other than non-melanoma skin cancer) requiring treatment in the past year, unless prognosis is excellent
  • Factors that may affect HbA1c: hemoglobin <11 mg/dL (cutpoint for moderate-to-severe anemia, which could lead to falsely elevated or lowered HbA1c); recent blood donation or blood transfusion (self-report, past 4 months); human immunodeficiency virus (self-report)
  • Allergies to nuts
  • For women, current pregnancy, breastfeeding, or plans to become pregnant during the study
  • Consumption of ≥21 alcoholic drinks per week or consumption of ≥6 drinks per occasion
  • Current or planned residence making it difficult to meet trial requirements (due to distance from study site and/or challenges regularly traveling to site)
  • Current participation in another lifestyle intervention trial or a pharmaceutical trial
  • Participation of another household member in the study; employees or persons living with employees of the study
  • Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675360


Contacts
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Contact: Mariel Dronson, MPH 504.988.4331 mdronson@tulane.edu
Contact: Erin Mahone, RN, MPH (504)988-4361 emahone@tulane.edu

Locations
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United States, Louisiana
Tulane Office of Health Research Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Mariel Dronson, MPH    504-988-4331    mdronson@tulane.edu   
Contact: Erin Mahone, RN, MPH    (504)988-4361    emahone@tulane.edu   
Sponsors and Collaborators
Tulane University School of Public Health and Tropical Medicine
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Kirsten Dorans, ScD Tulane University School of Public Health and Tropical Medicine

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Responsible Party: Kirsten Dorans, Assistant Professor, Tulane University School of Public Health and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03675360     History of Changes
Other Study ID Numbers: 2018-053
P20GM109036 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kirsten Dorans, Tulane University School of Public Health and Tropical Medicine:
Prediabetes
Diabetes
Low-Carbohydrate Diet

Additional relevant MeSH terms:
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Diabetes Mellitus
Hyperglycemia
Prediabetic State
Glucose Intolerance
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases