DiabetesADEPTNCT03675360
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
A study testing Low-Carbohydrate Diet in people with Diabetes and PreDiabetes, run by Tulane University School of Public Health and Tropical Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, PreDiabetes, Metabolic Disease
- What is being tested?
- Low-Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women ages 40 to 70 years
- HbA1c 6.0-6.9%
- Willing and able to provide informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane Office of Health Research
New Orleans, Louisiana, 70112
About this study
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.
Read the 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.
- Conditions
- Diabetes, PreDiabetes, Metabolic Disease, Hyperglycemia, Diet Modification, Glucose Intolerance
- Being tested
- Low-Carbohydrate Diet
- Keywords
- Prediabetes, Diabetes, Low-Carbohydrate Diet
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Metabolic Diseases, Hyperglycemia, Glucose Intolerance, Glucose Metabolism Disorders, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carbohydrate DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
Measured: Baseline and six months
Secondary outcomes (4)
Change in Fasting Plasma Glucose
6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm
Measured: Baseline and six months
Change in Systolic Blood Pressure
6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm
Measured: Baseline and six months
Change in Total-to-HDL-cholesterol Ratio
6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm
Measured: Baseline and six months
Change in Body Weight
6-month change in body weight comparing low-carbohydrate arm with usual diet arm
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start25 Sep 2018
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Public Health and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Kirsten Dorans, Tulane University School of Public Health and Tropical Medicine
- Investigators
- Kirsten Dorans, ScD, Principal investigator, Tulane University School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675360
- Sponsor's protocol ID
- 2018-053
- Other IDs
- P20GM109036
- Acronym
- ADEPT
- Status last verified
- Jan 2023
- First submitted
- 14 Sep 2018
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36287562Dorans 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.
PubMed 33522954
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
- ClinicalTrials.gov ID
- NCT03675360
- Acronym / sponsor ID
- ADEPT / 2018-053
- Conditions
- Diabetes, PreDiabetes, Metabolic Disease, Hyperglycemia, Diet Modification, Glucose Intolerance
- Keywords
- Prediabetes, Diabetes, Low-Carbohydrate Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tulane University School of Public Health and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Carbohydrate Diet | Experimental | Behavioral: Low-Carbohydrate DietBehavioral 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. |
| Usual Diet | No intervention | –No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ages 40 to 70 years
- HbA1c 6.0-6.9%
- Willing and able to provide informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carbohydrate DietBehavioral 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. | Behavioural | Low-Carbohydrate Diet |
Primary outcome
Change in Hemoglobin A1c
Time frame: Baseline and six months
6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm
4 secondary outcomes
Change in Fasting Plasma Glucose
Time frame: Baseline and six months
Change in Systolic Blood Pressure
Time frame: Baseline and six months
Change in Total-to-HDL-cholesterol Ratio
Time frame: Baseline and six months
Change in Body Weight
Time frame: Baseline and six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36287562Dorans 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.
- Derived from this study: PubMed 33522954Dorans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Dorans, ScD principal investigator
Tulane University School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carbohydrate Diet in people with Diabetes and PreDiabetes, run by Tulane University School of Public Health and Tropical Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: Baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.