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Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes (CHO-free diet)

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ClinicalTrials.gov Identifier: NCT01469104
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results in a change in blood glucose that is similar to the change observed after 3 days of fasting.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: 3 day fast Other: 3 day CHO-free diet Not Applicable

Detailed Description:
In addition to plasma glucose concentrations, other hormones and metabolites known to be affected by fasting will be measured. These include insulin and glucagon, which are hormones that have an important role in regulating fuel use in the body.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Study Start Date : August 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 3 day fast
After receiving a standard diet on day 1, subject will fast on days 2, 3, and 4. Water and calorie-fee beverages will be allowed during this 72 hour period.
 Other: 3 day fast
Subjects will fast for 72 hours
Other Name: 3-Day Fast
Active Comparator: CHO-free diet
After receiving a standard diet on day 1, a carbohydrate-free diet will be provided on days 2, 3, and 4.
 Other: 3 day CHO-free diet
Subjects will receive a carbohydrate-free diet for 72 hours
Other Name: Carbohydrate-free diet


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma glucose concentration [ Time Frame: 24 hour profile:before and after meals, or traditional meal times ]

Secondary Outcome Measures :
  1. Change in serum insulin concentrations [ Time Frame: 24 hour profiles: before and after meals or traditional meal times ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • C-peptide > 1.5 ng/ml

Exclusion Criteria:

  • Body mass index > 40
  • hematological abnormalities
  • liver disease
  • kidney disease
  • congestive heart failure
  • life threatening malignancies
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469104


Locations
United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Frank Q. Nuttall, M.D., Ph.D. Minneapolis VA Health Care System
Principal Investigator: Mary C. Gannon, Ph.D. Minneapolis VA Health Care System
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frank Q. Nuttall, MD, PhD, Chief, Endocrinology, Metabolism & Nutrition Section, Professor of Medicine, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01469104     History of Changes
Other Study ID Numbers: 4177
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases