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:

MedlinePlus related topics: Diabetes Diabetes Type 2

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Minneapolis Veterans Affairs Medical Center

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

Nuttall FQ, Almokayyad RM, Gannon MC. Comparison of a carbohydrate-free diet vs. fasting on plasma glucose, insulin and glucagon in type 2 diabetes. Metabolism. 2015 Feb;64(2):253-62. doi: 10.1016/j.metabol.2014.10.004. Epub 2014 Oct 8.


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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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