Trial Outcomes & Findings for Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects (NCT NCT02673203)

Results Overview

The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3-5 days

Results posted on

2022-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Typical Weight Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants Non-diabetic participants with a BMI \> 30 kg/m2.
Overall Study STARTED	16	15
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.	Total n=31 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 12.0 • n=93 Participants	40.4 years STANDARD_DEVIATION 14.1 • n=4 Participants	39 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Race/Ethnicity, Customized African American	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	15 participants n=4 Participants	31 participants n=27 Participants
Weight (kg)	67.8 kg STANDARD_DEVIATION 12.0 • n=93 Participants	90.6 kg STANDARD_DEVIATION 12.6 • n=4 Participants	79.3 kg STANDARD_DEVIATION 21.8 • n=27 Participants
A1c (%)	5.2 % STANDARD_DEVIATION 0.4 • n=93 Participants	5.1 % STANDARD_DEVIATION 0.7 • n=4 Participants	5.1 % STANDARD_DEVIATION 0.6 • n=27 Participants
BMI (kg/m2)	23.5 kg/m2 STANDARD_DEVIATION 1.7 • n=93 Participants	33.4 kg/m2 STANDARD_DEVIATION 2.2 • n=4 Participants	28.3 kg/m2 STANDARD_DEVIATION 5.4 • n=27 Participants

PRIMARY outcome

Timeframe: 3-5 days

The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Rate of Changing Glucose Level	0.52 mg/dl/min Interval 0.47 to 0.57	0.44 mg/dl/min Interval 0.38 to 0.49

PRIMARY outcome

Timeframe: 3-5 days

The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Glucose Peak	119.5 mg/dl Interval 111.5 to 127.6	121.5 mg/dl Interval 113.1 to 130.0

PRIMARY outcome

Timeframe: 3-5 days

The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Glucose Nadir	85.1 mg/dl Interval 79.7 to 90.4	87.1 mg/dl Interval 81.4 to 92.7

SECONDARY outcome

Timeframe: 3-5 days

The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Difference in Glucose Peak and Nadir	34.3 mg/dl Interval 29.8 to 38.8	33.9 mg/dl Interval 29.0 to 38.7

SECONDARY outcome

Timeframe: 3-5 days

Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Average Daily Hunger Rating	5.8 score on a scale Interval 5.1 to 6.5	5.6 score on a scale Interval 4.9 to 6.4

SECONDARY outcome

Timeframe: 3-5 days

Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Nutirion Intake: Energy	2251.5 kcal/day Interval 1841.1 to 2661.8	2167.8 kcal/day Interval 1782.1 to 2553.5

SECONDARY outcome

Timeframe: 3-5 days

Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Nutirion Intake: Carbohydrate	261.1 g/day Interval 212.2 to 310.0	251.8 g/day Interval 204.5 to 297.1

SECONDARY outcome

Timeframe: 3-5 days

Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Nutirion Intake: Fat	92.4 g/day Interval 68.3 to 116.5	97.5 g/day Interval 74.9 to 120.1

SECONDARY outcome

Timeframe: 3-5 days

Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day).

Outcome measures

Outcome measures
Measure	Typical Weight Participants n=16 Participants Participants with a BMI \<25 kg/m2.	Obese Non-diabetic Pariticpants n=15 Participants Non-diabetic participants with a BMI \> 30 kg/m2.
Nutirion Intake: Protein	99.9 g/day Interval 81.2 to 118.5	80.9 g/day Interval 61.9 to 97.9

Adverse Events

Typical Weight Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Non-diabetic Pariticpants

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

Renata Belfort De Aguiar, MD, PhD; Assistant Professor of Medicine (Endocrinology)

Yale University School of Medicine

Phone: (877) 925-3637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place