Ketogenic vs Low Fat Diet for Type 2 Diabetes Prevention

(KDDP Trial)

Overseen By Matthew Bouchonville, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must not be taking: Insulin

Disqualifiers: Cardiovascular disease, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet. The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the ketogenic diet safe for humans?

Based on available evidence, a well-formulated ketogenic diet does not appear to have major safety concerns for the general public and can be considered a first-line approach for obesity and diabetes. However, there are concerns about potential issues like poor growth and kidney stones, especially in children, when used long-term. ^{1 2 3 4 5}

How does the ketogenic diet differ from other treatments for preventing type 2 diabetes?

The ketogenic diet is unique because it focuses on very low carbohydrate intake and high fat consumption, which can lead to reduced blood sugar and insulin levels, potentially offering metabolic benefits not seen with low-fat diets. Unlike traditional low-fat diets, the ketogenic diet may be more effective for weight loss and managing diabetes, although concerns about high saturated fat intake exist. ^{1 6 7 8 9}

What data supports the effectiveness of the ketogenic diet treatment for type 2 diabetes prevention?

Research shows that a low-carbohydrate, high-fat ketogenic diet can improve blood sugar control in people with type 2 diabetes, as seen in cases where patients reduced their medication needs and improved their blood sugar levels. Additionally, studies indicate that low-carbohydrate diets can be as effective as low-fat diets in managing weight and other health markers, which are important for diabetes prevention. ^{6 10 11 12 13}

Who Is on the Research Team?

Kristen Gonzales, MD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with type 2 diabetes or prediabetes, who have a BMI of 27 or higher. It's not for pregnant individuals, those with type 1 diabetes, very high LDL cholesterol or triglycerides, history of serious heart conditions, insulin users, or people with advanced kidney/liver disease or terminal cancer.

Inclusion Criteria

You have a body mass index (BMI) of 27 or higher.

Your blood sugar levels are higher than normal.

Exclusion Criteria

I have had diabetic ketoacidosis in the past.

My condition is advanced liver disease.

I have a history of heart or blood vessel diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measures at study entry will include weight, height, systolic and diastolic blood pressure, heart rate, hemoglobin A1c, fasting plasma glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol.

1 week

1 visit (in-person)

Treatment

Participants in the KDDP arm will follow a ketogenic diet and attend weekly educational sessions. Participants in the NDPP arm will follow a low fat diet with identical follow-up.

12 months

Weekly educational sessions (in-person)

Follow-up

Participants are monitored for changes in weight, heart rate, HbA1c, fasting lipids, fasting plasma glucose, CAC scores, and blood pressure every 3 months and at study completion.

12 months

Quarterly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet
• Low Fat Diet

Trial Overview The study compares two diets: a medically-supervised ketogenic diet (KDDP) versus a low fat diet (NDPP). Over the course of one year, it will measure their effects on blood sugar control, cholesterol levels, blood pressure, heart rate, weight loss and heart artery health.

How Is the Trial Designed?

Group I: NDPP Experimental Treatment 1 Intervention

NDPP - Participants enrolled in the NDPP arm will be placed on a low fat diet.

Group II: KDDP Experimental Treatment 1 Intervention

KDDP - Participants enrolled in the KDDP arm will be placed on a traditional ketogenic diet (\<20 grams of carbohydrate/day).

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

In an 8-week study involving 24 overweight/obese participants, both low-fat and low-carbohydrate diets led to significant weight loss and similar improvements in insulin resistance, indicating that both diets can be effective for weight reduction.

However, the low-fat diet resulted in a significant decrease in arterial stiffness, suggesting that low-carbohydrate diets may have a negative impact on vascular health despite similar effects on insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance, and cardiovascular risk: a randomized control trial. Bradley, U., Spence, M., Courtney, CH., et al.[2021]

A low-carbohydrate, high-fat ketogenic diet (KD) was effective in improving glycemic control in two type 2 diabetic patients over a 12-week period, with both patients showing significant reductions in HBA1C levels (2.4% and 2.5%).

The female patient was able to reduce her diabetic medication by 75%, while the male patient eliminated all diabetic medications, highlighting the potential of KDs as a viable dietary strategy for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing glycemic control in type 2 diabetic patients through the use of a low-carbohydrate, high-fat, ketogenic diet: a review of two patients in primary care. Rallis, S.[2020]

Pre-ketogenic diet counseling is essential for patients with obesity and diabetes, focusing on understanding the risks and benefits of the diet, as well as the patient's self-care responsibilities.

This communication highlights the need for patient-centered counseling strategies, which have been largely overlooked in existing literature on ketogenic diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre ketogenic diet counselling. Kalra, S., Singla, R., Rosha, R., et al.[2019]

Low-carbohydrate (LC) diets have been shown to be as effective, or even more effective, than low-fat (LF) diets for weight loss and improving cardiovascular risk factors, based on both short-term and long-term studies.

The review suggests that LC diets can positively impact metabolic and hormonal responses, making them a viable alternative for managing obesity, diabetes, and heart disease risk in the American population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet review: shifting the paradigm. Hite, AH., Berkowitz, VG., Berkowitz, K.[2011]

A meta-analysis of 22 randomized controlled trials involving 1391 participants with type 2 diabetes found that a low carbohydrate (LC) diet significantly reduced HbA1c levels and body weight compared to a low fat (LF) diet at the short-term (3 months).

While the LC diet showed benefits in reducing HbA1c and adiposity in the short-to-intermediate term, it was found to be equally effective as the LF diet in controlling other cardiometabolic markers and had similar risks of adverse events over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effectiveness of Low Carbohydrate Versus Low Fat Diets, in Type 2 Diabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Apekey, TA., Maynard, MJ., Kittana, M., et al.[2022]

Ketogenic diets, which consist of over 70% fat and very low carbohydrates, may be more effective than low-fat diets for treating obesity and diabetes, showing potential benefits in reducing blood glucose and insulin levels.

A well-formulated ketogenic diet appears to be safe for the general public and could be considered a first-line treatment for obesity and diabetes, although more high-quality clinical trials are needed to explore its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. Ludwig, DS.[2023]

In a 14-month study involving 89 overweight and obese participants, a moderate-fat diet (30% energy from fat) led to significantly greater weight loss and reductions in waist circumference compared to a low-fat diet (20% energy from fat).

The moderate-fat diet also showed more favorable effects on cardiovascular risk factors, including lower LDL cholesterol and blood pressure, suggesting it may be a better long-term dietary option for weight maintenance and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better dietary adherence and weight maintenance achieved by a long-term moderate-fat diet. Azadbakht, L., Mirmiran, P., Esmaillzadeh, A., et al.[2007]

In a study involving 11 healthy, normal-weight participants, a high-fat ketogenic diet (KD) did not improve cognitive function, mood, or sleep quality compared to a high-carbohydrate, low-fat diet over a 3-week period.

Despite achieving nutritional ketosis, the KD showed no significant effects on tasks measuring vigilance, memory, or executive function, indicating that this diet may not enhance cognitive performance in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial. Iacovides, S., Goble, D., Paterson, B., et al.[2023]

Low-carbohydrate diets (LCDs) significantly reduced HbA1c levels by 0.35% and led to greater body weight loss compared to low-fat diets (LFDs) in type 2 diabetes patients, based on a review of 12 randomized controlled trials involving 761 participants.

LCDs also improved cardiovascular risk factors by lowering triglycerides and increasing HDL cholesterol, with these benefits lasting up to 2 years, although the weight loss effects diminished after 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy and Safety of Low-Carbohydrate Diets with Low-Fat Diets for Type 2 Diabetes Mellitus Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Li, S., Ding, L., Xiao, X.[2022]

The ketogenic diet (KD) has been associated with several health concerns in children, including poor growth, dyslipidemia, and kidney stones, raising questions about its long-term safety.

Despite these concerns, emerging evidence suggests that the KD may offer beneficial long-term health effects beyond its primary use in controlling seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term health consequences of epilepsy diet treatments. Vining, EP.[2022]

In a study involving 164 participants over 20 weeks, a low-carbohydrate diet high in saturated fat significantly improved insulin resistance and reduced lipoprotein(a) levels, suggesting potential cardiovascular benefits.

The low-carb diet did not adversely affect LDL cholesterol levels, indicating that carbohydrate restriction may lower cardiovascular disease risk without negative impacts on cholesterol profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. Ebbeling, CB., Knapp, A., Johnson, A., et al.[2023]

A 4-year-old girl with a rare FBXL4 gene mutation and severe lactic acidosis was successfully treated with a ketogenic diet (KD) after standard treatments failed, highlighting the KD's potential in managing mitochondrial disorders.

This case represents the first documented use of parenteral KD to effectively reduce lactic acidosis in a patient with mitochondrial depletion syndrome, suggesting a promising nonpharmacological intervention for similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. İnci, A., Aktaş, E., Cengiz Ergin, FB., et al.[2022]

A 12-week study involving 60 overweight or obese patients newly diagnosed with type 2 diabetes showed that a ketogenic diet significantly improved weight, blood glucose, and lipid levels compared to a routine diabetes diet.

While the ketogenic diet was effective in managing diabetes-related metrics, participants found it harder to adhere to this diet long-term compared to the standard diabetes diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of periodic ketogenic diet on newly diagnosed overweight or obese patients with type 2 diabetes. Li, S., Lin, G., Chen, J., et al.[2022]

Citations

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

Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance, and cardiovascular risk: a randomized control trial. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Optimizing glycemic control in type 2 diabetic patients through the use of a low-carbohydrate, high-fat, ketogenic diet: a review of two patients in primary care. [2020]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Pre ketogenic diet counselling. [2019]

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

Low-carbohydrate diet review: shifting the paradigm. [2011]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the Effectiveness of Low Carbohydrate Versus Low Fat Diets, in Type 2 Diabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

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

The Ketogenic Diet: Evidence for Optimism but High-Quality Research Needed. [2023]

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

Better dietary adherence and weight maintenance achieved by a long-term moderate-fat diet. [2007]

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

Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial. [2023]

9. Egypt pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy and Safety of Low-Carbohydrate Diets with Low-Fat Diets for Type 2 Diabetes Mellitus Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2022]

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

Long-term health consequences of epilepsy diet treatments. [2022]

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

Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. [2023]

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

The first case with FBXL4 mutation successfully treated with a parenteral ketogenic diet for lactic acidosis. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The effect of periodic ketogenic diet on newly diagnosed overweight or obese patients with type 2 diabetes. [2022]