Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-31 @ 12:00 AM
Study NCT ID:
NCT00006432
Status:
COMPLETED
Last Update Posted:
2007-06-25
First Post:
2000-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-22', 'studyFirstSubmitDate': '2000-11-03', 'studyFirstSubmitQcDate': '2000-11-03', 'lastUpdatePostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-11-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'descriptionModule': {'briefSummary': 'There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes, not tightly controlled at present\n* Not using medication (insulin or oral) to control blood sugar\n* Overweight, but generally healthy'}, 'identificationModule': {'nctId': 'NCT00006432', 'briefTitle': 'Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': 'NCRR-M01RR00030-0152'}, 'secondaryIdInfos': [{'id': 'M01RR000030', 'link': 'https://reporter.nih.gov/quickSearch/M01RR000030', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'very low fat diet', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Richard S. Surwit, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Procter and Gamble', 'class': 'INDUSTRY'}, {'name': 'Jenny Craig, Inc.', 'class': 'INDUSTRY'}]}}}