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Ketogenic Diet and Diabetes Demonstration Project

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 12-month study compares a medically supervised ketogenic (keto) diet program with a low-fat diet program. It is for adults with type 2 diabetes or prediabetes, which means blood sugar is higher than normal. The study looks at blood sugar, blood fats, blood pressure, heart rate, weight, and calcium buildup in the heart's arteries.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Body mass index (BMI), a measure of weight compared with height, of 27 or higher.
  • A1c (average blood sugar) of 5.7% or higher, fasting blood sugar of 100–125 mg/dL, or both.

Who can't join

  • Known heart or blood vessel disease, such as a past stroke, heart attack, or poor blood flow in the limbs.
  • LDL (bad cholesterol) of 190 mg/dL or higher.
  • Triglycerides (a type of blood fat) of 500 mg/dL or higher.
  • History of type 1 diabetes or diabetic ketoacidosis, a dangerous buildup of acids in the blood.
  • Need to use insulin.
  • Advanced kidney or liver disease.
  • Terminal cancer, meaning cancer that is expected to cause death.
  • Pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Men and women ≥ 18 years old * BMI ≥27 kg/m2 * Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL Exclusion Criteria: * Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease) * LDL cholesterol ≥ 190 mg/dL * Triglycerides ≥ 500 mg/dL * History of type 1 diabetes * History of diabetic ketoacidosis * Individuals requiring insulin * Advanced renal disease * Advanced liver disease * Terminal cancer * Pregnancy

Study sites (1)

NM