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Trial of New Dietary Treatment of Diabetes

Phase 1 Trial of A New Dietary Treatment of Obesity Related Type 2 Diabetes

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00128089
Enrollment
10
Registered
2005-08-09
Start date
2005-08-31
Completion date
2005-12-31
Last updated
2005-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Obesity, Dietary treatment, Fasting as medical therapy

Brief summary

This is a preliminary trial of a new dietary approach to the treatment of obesity related type 2 diabetes. Study terminated December 19, 2005 for administrative reasons.

Detailed description

Traditional dietary treatment of type 2 diabetes is complicated and often fails. This is a dietary treatment that uses fingerstick testing of blood sugars and a remarkably simple algorithm to promptly lower the blood glucose to treatment goals. A series of 10 overweight type 2 diabetic patients not well controlled, or needing medication for control, will be recruited to follow this plan; followup is to be until 6 months after the last patient is enrolled, or when all patients have normal A1Cs with no medication, whichever comes first. Primary endpoints to be measured are A1C, weight loss (in pounds and BMI reduction) and medication reduction. Secondary endpoints are occurrences of hypoglycemia, reduction of medications for hypertension and hyperlipidemia, and patient satisfaction. As this is a Phase 1 trial, the only control group is historical controls (the patients themselves and the medical literature).

Interventions

Sponsors

Manassas Internal Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Diabetes mellitus, type 2 * Obesity * Ability to attend office visits in Manassas, Virginia

Exclusion criteria

* Dementia * Institutionalized living * Retinopathy, neuropathy * Pregnancy * Serious health problems such as heart disease or stroke

Design outcomes

Primary

MeasureTime frame
Glycated hemoglobin (A1C) changes
Weight (body mass index [BMI]) loss
Diabetes medication reduction

Secondary

MeasureTime frame
Hypoglycemia
Other medication reduction
Patient satisfaction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026