Low-Carb Diet for Type 2 Diabetes
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.12345Why 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.13456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to either a low-carb diet or a standard diabetes diet for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Children's of Alabama
Collaborator
Published Research Related to This Trial
Citations
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 ...
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.
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 ...
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 ...
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 ...
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 ...
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