NCT00108459

Brief Summary

This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 21, 2009

Status Verified

July 1, 2007

First QC Date

April 15, 2005

Last Update Submit

January 20, 2009

Conditions

ObesityType 2 DiabetesHyperlipidemia

Keywords

ObesityType 2 DiabetesHyperlipidemiaInsulin resistance

Interventions

Low Carbohydrate DietBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects \> 18 years of age
  • Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
  • Body mass index of \> 30 kg/m2
  • The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Iqbal N, Vetter ML, Moore RH, Chittams JL, Dalton-Bakes CV, Dowd M, Williams-Smith C, Cardillo S, Wadden TA. Effects of a low-intensity intervention that prescribed a low-carbohydrate vs. a low-fat diet in obese, diabetic participants. Obesity (Silver Spring). 2010 Sep;18(9):1733-8. doi: 10.1038/oby.2009.460. Epub 2009 Dec 17.

    PMID: 20019677DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2HyperlipidemiasInsulin Resistance

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism DisordersHyperinsulinism

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Nayyar Iqbal

    VA Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2005

First Posted

April 18, 2005

Study Start

September 1, 2004

Study Completion

December 1, 2007

Last Updated

January 21, 2009

Record last verified: 2007-07

Locations

US(1)