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

Primary Purpose

Diabetes, PreDiabetes, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Carbohydrate Diet
Sponsored by
Tulane University School of Public Health and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Prediabetes, Diabetes, Low-Carbohydrate Diet

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)
  • Self-reported history of intensive care unit stay due to Coronavirus Disease 2019 (COVID-19) in the past three months, as severe COVID-19 may affect blood glucose levels
  • 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

Sites / Locations

  • Tulane Office of Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low-Carbohydrate Diet

Usual Diet

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm

Secondary Outcome Measures

Change in Fasting Plasma Glucose
6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm
Change in Systolic Blood Pressure
6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm
Change in Total-to-HDL-cholesterol Ratio
6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm
Change in Body Weight
6-month change in body weight comparing low-carbohydrate arm with usual diet arm

Full Information

First Posted
September 14, 2018
Last Updated
January 31, 2023
Sponsor
Tulane University School of Public Health and Tropical Medicine
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03675360
Brief Title
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Acronym
ADEPT
Official Title
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University School of Public Health and Tropical Medicine
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 150 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, PreDiabetes, Metabolic Disease, Hyperglycemia, Diet Modification, Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus), Endocrine System Diseases
Keywords
Prediabetes, Diabetes, Low-Carbohydrate Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Carbohydrate Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Diet
Arm Type
No Intervention
Arm Description
No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.
Intervention Type
Behavioral
Intervention Name(s)
Low-Carbohydrate Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose
Description
6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Systolic Blood Pressure
Description
6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Total-to-HDL-cholesterol Ratio
Description
6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Body Weight
Description
6-month change in body weight comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Other Pre-specified Outcome Measures:
Title
Change in Insulin
Description
6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Description
6-month change in HOMA-IR comparing low-carbohydrate arm with usual diet arm. HOMA-IR was calculated as fasting insulin (μIU/mL) x fasting glucose (mmol/L)/22.5.
Time Frame
Baseline and six months
Title
Change in Diastolic Blood Pressure
Description
6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Waist Circumference
Description
6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm
Time Frame
Baseline and six months
Title
Change in Estimated Atherosclerotic Cardiovascular Disease Risk
Description
6-month change in estimated 10-year atherosclerotic cardiovascular disease risk comparing low-carbohydrate arm with usual diet arm. The estimated 10-year cardiovascular disease risk was assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score, known as the Pooled Cohort Equations. The Pooled Cohort Equations estimate the 10-year primary risk of ASCVD (atherosclerotic cardiovascular disease) among patients without pre-existing cardiovascular disease who are between 40 and 79 years of age. Variables included in the risk score include: gender, age, race, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for blood pressure, diabetes, and smoking status. Reference: Goff DC, Lloyd-Jones DM et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: A report of the American college of cardiology/American heart association task force on practice guidelines. Vol. 129, Circulation. 2014.
Time Frame
Baseline and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) Self-reported history of intensive care unit stay due to Coronavirus Disease 2019 (COVID-19) in the past three months, as severe COVID-19 may affect blood glucose levels 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Dorans, ScD
Organizational Affiliation
Tulane University School of Public Health and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane Office of Health Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36287562
Citation
Dorans KS, Bazzano LA, Qi L, He H, Chen J, Appel LJ, Chen CS, Hsieh MH, Hu FB, Mills KT, Nguyen BT, O'Brien MJ, Samet JM, Uwaifo GI, He J. Effects of a Low-Carbohydrate Dietary Intervention on Hemoglobin A1c: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238645. doi: 10.1001/jamanetworkopen.2022.38645.
Results Reference
derived
PubMed Identifier
33522954
Citation
Dorans KS, Bazzano LA, Qi L, He H, Appel LJ, Samet JM, Chen J, Mills KT, Nguyen BT, O'Brien MJ, Uwaifo GI, He J. Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial. Trials. 2021 Feb 1;22(1):108. doi: 10.1186/s13063-020-05001-x.
Results Reference
derived

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Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

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