LoBAG30 Diet in Patients on Metformin (LoBAG Diet)

• ClinicalTrials.gov Identifier: NCT00607867
• Recruitment Status: Terminated
• First Posted: February 6, 2008
• Results First Posted: December 12, 2014
• Last Update Posted: December 12, 2014
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Diabetes Mellitus; Diet
• Interventions: Other: LoBAG30 diet; Other: Control Diet
• Enrollment: 20

Participant Flow

Recruitment Details
Pre-assignment Details	Proposed study design was 20 subjects, 10/arm. (Parallel arm design requested by grant Reviewers.) At the end of the funding period, 14 subjects had been enrolled and studied, 7 in each arm.

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Period Title: Overall Study
Started	7	7
Completed	7	7
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		LoBAG30 Diet	Control Diet	Total
Arm/Group Description		A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.	A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat	Total of all reporting groups
Overall Number of Baseline Participants		7	7	14
Baseline Analysis Population Description		Subjects with type 2 diabetes being treated with metformin
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	7 participants	7 participants	14 participants
		62; (51 to 71)	61; (53 to 66)	61.6; (51 to 71)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	7 participants	7 participants	14 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	7 100.0%	7 100.0%	14 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	7 participants	7 participants	14 participants
		7	7	14

Outcome Measures

1. Primary Outcome

Title	Change in %Hemoglobin A1c at 5 Weeks From Baseline
Description	Hemoglobin A1c measured before and after 5 weeks on the diet
Time Frame	Baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: Change in % A1c at 5 weeks from baseli
	-0.9 (0.23)	-0.9 (0.16)

2. Primary Outcome

Title	Change in Total Glucose Area at 5 Weeks From Baseline
Description	The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.
Time Frame	Baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: mg hr/dl
	-957 (302)	-691 (84)

3. Primary Outcome

Title	Change in Body Weight at 5 Weeks From Baseline
Description	Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.
Time Frame	baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: pounds
	-0.7 (0.7)	-2.6 (1.0)

4. Primary Outcome

Title	Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline
Description	Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.
Time Frame	baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: mg/dl
	-22 (16.5)	-33 (4.7)

5. Secondary Outcome

Title	Microalbumin Excretion
Description	change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame	baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: mg/day
	-0.9 (4.2)	-8.3 (3.5)

6. Secondary Outcome

Title	Change in Fasting Triglycerides at 5 Weeks From Baseline
Description	Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention
Time Frame	baseline and 5 weeks after dietary intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description:	A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Number of Participants Analyzed	7	7
Mean (Standard Error); Unit of Measure: mg/dl
	-18 (12.9)	-24 (9.9)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	LoBAG30 Diet	Control Diet
Arm/Group Description	A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks. LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.	A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks. Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat
All-Cause Mortality
	LoBAG30 Diet	Control Diet
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	LoBAG30 Diet	Control Diet
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/7 (0.00%)	0/7 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	LoBAG30 Diet	Control Diet
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0

Limitations and Caveats

Funding ended with only 14 subjects studied. With a parallel arm design, we were not able to draw any conclusions from the study. Funds were unavailable for a more sophisticated statistical analysis.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Mary C. Gannon, Ph.D.
• Organization: Minneapolis VA Health Care System, Metabolic Research Labortory
• Phone: 6124672895
• EMail: ganno004@umn.edu

• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• ClinicalTrials.gov Identifier: NCT00607867
• Other Study ID Numbers: CLIN-010-07F
• First Submitted: January 31, 2008
• First Posted: February 6, 2008
• Results First Submitted: November 17, 2014
• Results First Posted: December 12, 2014
• Last Update Posted: December 12, 2014