Trial Outcomes & Findings for LoBAG30 Diet in Patients on Metformin (NCT NCT00607867)

Results Overview

Hemoglobin A1c measured before and after 5 weeks on the diet

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 5 weeks after dietary intervention

Results posted on

2014-12-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	LoBAG30 Diet A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LoBAG30 Diet in Patients on Metformin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.	Control Diet n=7 Participants A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat	Total n=14 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	61 years n=7 Participants	61.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5 weeks after dietary intervention

Hemoglobin A1c measured before and after 5 weeks on the diet

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Change in %Hemoglobin A1c at 5 Weeks From Baseline	-0.9 Change in % A1c at 5 weeks from baseli Standard Error 0.23	-0.9 Change in % A1c at 5 weeks from baseli Standard Error 0.16

PRIMARY outcome

Timeframe: Baseline and 5 weeks after dietary intervention

The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Change in Total Glucose Area at 5 Weeks From Baseline	-957 mg hr/dl Standard Error 302	-691 mg hr/dl Standard Error 84

PRIMARY outcome

Timeframe: baseline and 5 weeks after dietary intervention

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.

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Change in Body Weight at 5 Weeks From Baseline	-0.7 pounds Standard Error 0.7	-2.6 pounds Standard Error 1.0

PRIMARY outcome

Timeframe: baseline and 5 weeks after dietary intervention

Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline	-22 mg/dl Standard Error 16.5	-33 mg/dl Standard Error 4.7

SECONDARY outcome

Timeframe: baseline and 5 weeks after dietary intervention

change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Microalbumin Excretion	-0.9 mg/day Standard Error 4.2	-8.3 mg/day Standard Error 3.5

SECONDARY outcome

Timeframe: baseline and 5 weeks after dietary intervention

Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention

Outcome measures

Outcome measures
Measure	LoBAG30 Diet n=7 Participants A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat	Control Diet n=7 Participants A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
Change in Fasting Triglycerides at 5 Weeks From Baseline	-18 mg/dl Standard Error 12.9	-24 mg/dl Standard Error 9.9

Adverse Events

LoBAG30 Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary C. Gannon, Ph.D.

Minneapolis VA Health Care System, Metabolic Research Labortory

Phone: 6124672895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place