Treatment of Type 2 Diabetes With Ketogenic Diet

Status unconfirmed · Not applicable

Conditions studied: Type2 Diabetes Mellitus, Obesity

In brief

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.

Key facts

Study ID

NCT03652649

Run by

Mid-Atlantic Epilepsy and Sleep Center, LLC

People needed

50

Starts

2017-11-01

Expected to finish

2020-11-01

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• History of bariatric surgery ≤ 2 years prior to enrollment.
• 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.
• History of uncontrolled hyperlipidemia
• Change in the dose or type of hypoglycemic treatment within 1 month prior to enrollment.
• Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
• Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
• History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
• Pregnancy
• Use of any investigational drugs within 3 months of enrollment.
• Inability or unwillingness of subject to give written informed consent.

Where it is running

• Ivana Tyrlikova — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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