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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of a low-carb diet on teenagers with type 2 diabetes over 24 weeks. The goal is to determine if reducing carbohydrate intake manages diabetes more effectively than a standard balanced diet. Participants will either follow a low-carb plan (50-80 grams of carbs per day) or adhere to the standard diabetes diet, with both groups receiving guidance from a dietitian. This trial suits teens who have had type 2 diabetes for at least three months, have a BMI above the 85th percentile, and are not on insulin. As an Early Phase 1 trial, this research aims to understand how the low-carb diet functions in individuals, offering participants the opportunity to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that low-carb diets are generally safe for people with type 2 diabetes. Studies have found that these diets can improve blood sugar control and promote weight loss. In one study, participants on a low-carb diet had better blood sugar levels than those on regular diets.

Another study examined the long-term effects and found that low-carb diets help manage diabetes without major safety concerns. Some individuals might experience mild side effects, such as changes in energy levels or digestion, but these are usually temporary.

Overall, people with type 2 diabetes have tolerated low-carb diets well, making them a promising option for managing the condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the low-carb diet for managing type 2 diabetes because it approaches the condition by significantly reducing carbohydrate intake, which is unlike the standard diabetes care that includes balanced meals with carbohydrates. This diet emphasizes consuming more proteins, healthy fats, and non-starchy vegetables, potentially helping to better manage blood sugar levels by minimizing glucose spikes. By focusing on a lower carb intake, participants might experience improved insulin sensitivity and weight management, offering a promising alternative to traditional dietary guidelines.

What evidence suggests that a low carb diet might be an effective treatment for type 2 diabetes?

Research has shown that a low-carb diet, which participants in this trial may follow, can help manage type 2 diabetes. Studies have found that people on low-carb diets often experience reductions in blood sugar levels. For example, one study found that participants' HbA1c levels, which measure long-term blood sugar control, dropped by 0.29%, and their fasting blood sugar decreased by 7.12 mg/dL. Additionally, low-carb diets are associated with weight loss, which can further aid in managing diabetes. Over six months, these diets have also led to higher rates of diabetes remission, meaning more people reached normal blood sugar levels. These findings suggest that a low-carb diet might be a promising way to control diabetes in the short term. ^{1 3 4 5 6}

Who Is on the Research Team?

Ortal Resnick, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004784

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs improved glycemia short-term: HbA1c − 0.29 %, with the largest effect at 3 months. Fasting blood glucose decreased overall (−7.12 mg/dL). Weight loss was ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4674467/

Low Carbohydrate Diets and Type 2 Diabetes - PubMed Central Low carbohydrate diets in people with type 2 diabetes were effective for short-term improvements in glycemic control, weight loss, and cardiovascular risk.

3. nature.com nature.com/articles/s41387-023-00240-8

results of the T2Diet Study randomised controlled trial Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published ...

4. bmj.com bmj.com/content/372/bmj.m4743

Efficacy and safety of low and very low carbohydrate diets ... At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA1c <6.5%) (76/133 (57%) v 41/131 (31 ...

5. cureus.com cureus.com/articles/394630-long-term-efficacy-and-safety-of-a-low-carbohydrate-diet-in-type-2-diabetes-remission-a-systematic-review

Long-Term Efficacy and Safety of a Low-Carbohydrate Diet ... LCDs have shown effectiveness in inducing weight loss, a critical factor in improving T2D management. Weight reduction enhances insulin ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131143/

Low‐carbohydrate diet for people with type 2 diabetes mellitus A very low‐carbohydrate diet (VLCD) contained 50 g or less of carbohydrates per day or 10% of the total caloric value per day [23]. The VLCD is ...