Trial Outcomes & Findings for The LoBAG Diet and Type 2 Diabetes Mellitus (NCT NCT02717078)
NCT ID: NCT02717078
Last Updated: 2024-07-26
Results Overview
Marker of blood sugar control
COMPLETED
NA
48 participants
Week 12
2024-07-26
Participant Flow
Participant milestones
| Measure |
LoBAG Diet
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
Control Diet
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The LoBAG Diet and Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LoBAG Diet
n=24 Participants
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
Control Diet
n=24 Participants
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
57.4 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 12Marker of blood sugar control
Outcome measures
| Measure |
LoBAG Diet
n=20 Participants
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
Control Diet
n=18 Participants
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
|---|---|---|
|
Change in Hemoglobin A1c From Baseline to Week 12
|
6.6 percentage
Standard Deviation 0.6
|
7.2 percentage
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 12Weight in pounds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Blood draw
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Blood draw
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineA meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12A marker of blood sugar control, similar to hemoglobin A1c
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Blood draw
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineUrine sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 3Urine sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Urine sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 9Urine sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Urine sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineMeal record for 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Meal record for 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Meal record for 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 9Interview to review meals consumed in previous 24 hours
Outcome measures
Outcome data not reported
Adverse Events
LoBAG Diet
Control Diet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LoBAG Diet
n=24 participants at risk
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
Control Diet
n=24 participants at risk
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet.
|
|---|---|---|
|
General disorders
Nausea
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
|
Nervous system disorders
tingling/neuropathy symptoms
|
0.00%
0/24 • 12 weeks
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
|
Ear and labyrinth disorders
ear infection
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
|
General disorders
arm pain
|
0.00%
0/24 • 12 weeks
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/24 • 12 weeks
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
|
General disorders
back injury
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place