N/A
N=150
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Diabetes · PreDiabetes · Metabolic Disease · Hyperglycemia · Diet Modification
Bottom Line
View on ClinicalTrials.gov: NCT03675360 ↗Enrolled (actual)
150
Serious AEs
4.7%
Results posted
Mar 2023
Primary outcome: Primary: Change in Hemoglobin A1c — -0.26; -0.04 percentage — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-Carbohydrate Diet (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Tulane University School of Public Health and Tropical Medicine
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c |
-0.26; -0.04 | <0.05 sig |
| SECONDARY Change in Fasting Plasma Glucose |
-8.4; 1.9 | <0.05 sig |
| SECONDARY Change in Systolic Blood Pressure |
-4.9; -1.6 | <0.05 sig |
| SECONDARY Change in Total-to-HDL-cholesterol Ratio |
-0.54; -0.41 | <0.05 sig |
| SECONDARY Change in Body Weight |
-6.4; -0.5 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03675360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.