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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01469104
First received: November 8, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Other: 3 day fast
Other: 3 day CHO-free diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in plasma glucose concentration [ Time Frame: 24 hour profile:before and after meals, or traditional meal times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum insulin concentrations [ Time Frame: 24 hour profiles: before and after meals or traditional meal times ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 8, 2011
Last Updated: November 9, 2011
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Diabetes

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

ClinicalTrials.gov processed this record on May 23, 2013