Recruiting

Ketogenic Diet

Sponsor:

Mid-Atlantic Epilepsy and Sleep Center, LLC

Code:

NCT03652649

Conditions

Type2 Diabetes Mellitus

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

3:1 ratio Ketogenic diet

Study Details

Brief summary:

The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet.

Conditions

Type2 Diabetes Mellitus

Obesity

Study ID

NCT03652649

Start date

Nov 1, 2017

Status verified date

Aug, 2018

Completion date

Nov 1, 2020

Anticipated

Primary completion date

Nov 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18-70
2. Ability and willingness to sign informed consent form.
3. T2D with BMI ≥ 30 kg/m2
4. Stable hypoglycemic medications for at least 2 months

Exclusion Criteria:

1. History of bariatric surgery ≤ 2 years prior to enrollment.
2. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
3. History of uncontrolled hyperlipidemia
4. Change in the dose or type of hypoglycemic treatment within 1 month prior to enrollment.
5. Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
6. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
7. History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
8. Pregnancy
9. Use of any investigational drugs within 3 months of enrollment.
10. Inability or unwillingness of subject to give written informed consent.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3:1 Ketogenic Complete Meal Replacement

Evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day complete meal replacement ketogenic diet

Interventions

3:1 ratio Ketogenic diet

Type 2 Diabetic subjects with BMI greater than or equal to 30 are started on 3:1 ratio ketogenic complete meal replacement program and weight loss and glycemic control is tracked over 6 month intervention period

Primary outcome measure

  • Type 2 diabetes remission [ Time Frame: 6 months (study duration) ]

Central Contacts and Locations

Central contacts

Locations

Ivana Tyrlikova

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Principal Investigator:

Pavel Klein, MD

More Information

Sponsor

Mid-Atlantic Epilepsy and Sleep Center, LLC

Last update posted

Aug 29, 2018

Last verified

Aug, 2018

Keywords

  • type 2 diabetes
  • diabetes
  • ketogenic diet
  • low carb diet
  • weight loss
  • obesity
  • diet treatment
  • nutrition
  • BMI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mid-Atlantic Epilepsy and Sleep Center, LLC on 2018-08-29.