Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

NCT03675360 | Completed Results DMC

• 2 other identifiers: 2018-053P20GM109036
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

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

  Baseline and six months

Secondary Outcomes (4)

• Change in Fasting Plasma Glucose

  Baseline and six months

• Change in Systolic Blood Pressure

  Baseline and six months

• Change in Total-to-HDL-cholesterol Ratio

  Baseline and six months

• Change in Body Weight

  Baseline and six months

Other Outcomes (5)

• Change in Insulin

  Baseline and six months

• Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline and six months

• Change in Diastolic Blood Pressure

  Baseline and six months

Study Arms (2)

Low-Carbohydrate Diet

EXPERIMENTAL

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

Usual Diet

NO INTERVENTION

No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.

Interventions

Low-Carbohydrate Diet BEHAVIORAL

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.

Low-Carbohydrate Diet

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University School of Public Health and Tropical Medicine: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Tulane Office of Health Research

New Orleans, Louisiana, 70112, United States

Location

Related Publications (2)

• 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.

  PMID: 36287562 DERIVED

• 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.

  PMID: 33522954 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Glucose Metabolism Disorders; Endocrine System Diseases

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Kirsten Dorans, Assistant Professor, Department of Epidemiology
• Organization: Tulane University School of Public Health and Tropical Medicine

kdorans@tulane.edu

15049880883

Study Officials

• Kirsten Dorans, ScD

  Tulane University School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: September 25, 2018
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)