Low-Carb Diet for Type 2 Diabetes

Overseen By Ortal Resnick, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must be taking: Anti-diabetic drugs

Must not be taking: Insulin

Disqualifiers: Renal impairment, Hepatic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to test the effect of a low carb diet compared to standard carb diet among adolescents with T2D over a 24-week period.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current anti-diabetic medications like GLP-1, metformin, or SGLT-2 inhibitors for at least 3 months before joining.

What data supports the effectiveness of the low-carb diet treatment for type 2 diabetes?

Research shows that a low-carb diet can help people with type 2 diabetes lose weight and control their blood sugar levels better than a high-carb diet. These benefits were maintained over a long period, even without close follow-up. ^{1 2 3 4 5}

Is a low-carb diet safe for people with type 2 diabetes?

Research suggests that low-carb diets are generally safe for people with type 2 diabetes and can lead to weight loss and reduced medication needs. However, some concerns about safety remain, and it's important to discuss this diet with a healthcare provider. ^{3 6 7 8 9}

How does a low-carb diet differ from other treatments for type 2 diabetes?

A low-carb diet is unique for type 2 diabetes management because it focuses on reducing carbohydrate intake, which can help improve blood sugar control more effectively than high-carb diets. This approach is particularly suitable for people with type 2 diabetes, as it directly targets the body's ability to manage blood sugar levels. ^{3 4 10 11 12}

Research Team

Ortal Resnick, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adolescents aged 12-18 with Type 2 Diabetes, who have an HbA1C level between 6.5-8.5% and a BMI above the 85th percentile. Participants should not be on insulin but can be taking certain diabetes medications like GLP-1, metformin, or SGLT-2 inhibitors as long as doses have been stable for three months.

Inclusion Criteria

HbA1C between 6.5-8.5%

BMI >85th percentile

Negative pancreatic autoantibodies

Exclusion Criteria

I am currently being treated with insulin.

My kidney function is impaired with creatinine over 1 mg/dL.

My liver tests (AST and ALT) are above 100 IU/ml.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either a low-carb diet or a standard diabetes diet for 24 weeks

24 weeks

Regular meetings with a dietitian

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low Carb Diet

Trial Overview The study compares the effects of a low-carb diet to a standard diabetic diet over six months in young patients with Type 2 Diabetes. The goal is to see which diet better manages blood sugar levels.

Participant Groups

Group I: Low carb diet Active Control 1 Intervention

Participants in this group will limit the amount of carbohydrates they eat each day to 50-80 grams. This means eating fewer sugars and starches (like bread, pasta, rice, and sweets). Instead, meals will focus on protein, healthy fats, and non-starchy vegetables. Participants will track their food and meet with a dietitian to help them stick to the plan.

Group II: Standard of care Active Control 1 Intervention

Participants in this group will follow the current standard diet for managing diabetes. This includes balanced meals with carbohydrates, protein, and fats, based on regular diabetes guidelines. Participants will track their food and meet with a dietitian to help them stay on track.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Children's of Alabama

Collaborator

Trials

10

Recruited

3,000+

Findings from Research

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

In a study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in type 2 diabetes: stable improvement of bodyweight and glycemic control during 44 months follow-up. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet combined with SGLT2 inhibitor for refractory hyperglycemia caused by insulin antibodies. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Low and reduced carbohydrate diets: challenges and opportunities for type 2 diabetes management and prevention. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A web-based low carbohydrate diet intervention significantly improves glycaemic control in adults with type 2 diabetes: results of the T2Diet Study randomised controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in type 2 diabetes. Stable improvement of bodyweight and glycemic control during 22 months follow-up. [2020]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Benefits of Low Carbohydrate Diets: a Settled Question or Still Controversial? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Low Carbohydrate Diets and Type 2 Diabetes: What is the Latest Evidence? [2022]

11. England pubmed.ncbi.nlm.nih.gov

An evidence-based approach to developing low-carbohydrate diets for type 2 diabetes management: A systematic review of interventions and methods. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Acute metabolic responses to a high-carbohydrate meal in outpatients with type 2 diabetes treated with a low-carbohydrate diet: a crossover meal tolerance study. [2022]