NCT03652649

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

July 5, 2018

Last Update Submit

August 28, 2018

Conditions

Type2 Diabetes MellitusObesity

Keywords

type 2 diabetesdiabetesketogenic dietlow carb dietweight lossobesitydiet treatmentnutritionBMI

Outcome Measures

Primary Outcomes (1)

  • Type 2 diabetes remission

    Defined as normal fasting blood glucose (\<126), normal HbA1C (\<6.4%), and no diabetic medications

    6 months (study duration)

Secondary Outcomes (13)

  • Change from baseline in glucose blood level in patients with type 2 DM in 6 months.

    6 months (study duration)

  • Percentage of diabetic medication load reduction

    6 months (study duration)

  • Change from baseline in HbA1C in patients with type 2 DM in 6 months.

    0, 3 and 6 months treatment duration

  • Adverse events

    6 months (study duration)

  • Fasting serum insulin

    0, 3 and 6 months treatment duration

  • +8 more secondary outcomes

Study Arms (1)

3:1 Ketogenic Complete Meal Replacement

EXPERIMENTAL

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

Other: 3:1 ratio Ketogenic diet

Interventions

3:1 ratio Ketogenic dietOTHER

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

Also known as: Classic Ketogenic Diet
3:1 Ketogenic Complete Meal Replacement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivana Tyrlikova

Bethesda, Maryland, 20817, United States

RECRUITING

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Pavel Klein, M.B,B.Chir.

    Mid-Atlantic Epilepsy and Sleep Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Tyrlikova

CONTACT

3015309744tyrlikovai@epilepsydc.com

Lenka Goldman

CONTACT

3015309744

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

August 29, 2018

Study Start

November 1, 2017

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)