Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— CHO-free diet  

Official title:

Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469104
• Other study ID #: 4177
• Status: Completed
• Phase: N/A
• First received: November 8, 2011
• Last updated: November 9, 2011
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: November 2011
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 3 day fast
Subjects will fast for 72 hours
• 3 day CHO-free diet
Subjects will receive a carbohydrate-free diet for 72 hours

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma glucose concentration		24 hour profile:before and after meals, or traditional meal times	No
Secondary	Change in serum insulin concentrations		24 hour profiles: before and after meals or traditional meal times	No