Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

Diabetes Clinical Trial

— ADEPT  

Official title:

Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675360
• Other study ID #: 2018-053
• Secondary ID: P20GM109036
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: June 21, 2021

Study information

• Verified date: January 2023
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diet Modification
• Endocrine System Diseases
• Glucose Intolerance
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Hyperglycemia
• Metabolic Disease
• Metabolic Diseases
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Tulane Office of Health Research	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University School of Public Health and Tropical Medicine	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Insulin	6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Other	Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	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.	Baseline and six months
Other	Change in Diastolic Blood Pressure	6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Other	Change in Waist Circumference	6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Other	Change in Estimated Atherosclerotic Cardiovascular Disease Risk	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.	Baseline and six months
Primary	Change in Hemoglobin A1c	6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Secondary	Change in Fasting Plasma Glucose	6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Secondary	Change in Systolic Blood Pressure	6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Secondary	Change in Total-to-HDL-cholesterol Ratio	6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm	Baseline and six months
Secondary	Change in Body Weight	6-month change in body weight comparing low-carbohydrate arm with usual diet arm	Baseline and six months