Clinical trial NCT03675360: Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Official title: Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
PreDiabetes
Metabolic Disease
Hyperglycemia
Diet Modification
Glucose Intolerance
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Endocrine System Diseases
Keywords: Prediabetes
Diabetes
Low-Carbohydrate Diet
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-09-18
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Baseline and six months
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: Baseline and six months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and six months
measure: Change in Total-to-HDL-cholesterol Ratio
timeFrame: Baseline and six months
measure: Change in Body Weight
timeFrame: Baseline and six months
Other outcomes:
measure: Change in Insulin
timeFrame: Baseline and six months
measure: Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline and six months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and six months
measure: Change in Waist Circumference
timeFrame: Baseline and six months
measure: Change in Estimated Atherosclerotic Cardiovascular Disease Risk
timeFrame: Baseline and six months
Locations:
city: New Orleans
country: United States
facility: Tulane Office of Health Research
state: Louisiana
Study officials:
affiliation: Tulane University School of Public Health and Tropical Medicine
name: Kirsten Dorans, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.