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Trial Outcomes & Findings for Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes (NCT NCT04416204)

NCT ID: NCT04416204

Last Updated: 2024-03-01

Results Overview

We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

Results posted on

2024-03-01

Participant Flow

17 Type 2 Diabetes subjects were screened, 1 subject did not meet eligibility criteria, 2 subjects withdrew from the study. 17 subjects without Diabetes were screened, 2 subjects withdrew from the study.

Subject enrolled after consent were screened to meet inclusion criteria. If not met subjects were excluded. 14 Type 2 Diabetes and 15 without Diabetes subjects were randomized to receive, either Glycogen loading or Non-Glycogen loading meal during visit 1. All subjects were tested for Glycogen loading and Non-Glycogen loading meal in a randomized order. 1Type 2 Diabetes and 2 without Diabetes subjects did not participate in visit 2.

Participant milestones

Participant milestones
Measure
Type 2 Diabetes - GL Then NGL
Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout
Type 2 Diabetes - NGL Then GL
Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout
Participants Without Diabetes - GL Then NGL
Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout
Participants Without Diabetes - NGL Then GL
Participants with no Diabetes received Non-Glycogen loading (NGL)followed by Glycogen loading (GL) meal after 3-6 weeks of washout
First Visit
STARTED
6
8
7
8
First Visit
COMPLETED
6
8
7
8
First Visit
NOT COMPLETED
0
0
0
0
Washout (3-6 Weeks)
STARTED
6
8
7
8
Washout (3-6 Weeks)
COMPLETED
5
8
6
7
Washout (3-6 Weeks)
NOT COMPLETED
1
0
1
1
Second Visit
STARTED
5
8
6
7
Second Visit
COMPLETED
5
8
6
7
Second Visit
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Type 2 Diabetes - GL Then NGL
Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout
Type 2 Diabetes - NGL Then GL
Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout
Participants Without Diabetes - GL Then NGL
Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout
Participants Without Diabetes - NGL Then GL
Participants with no Diabetes received Non-Glycogen loading (NGL)followed by Glycogen loading (GL) meal after 3-6 weeks of washout
Washout (3-6 Weeks)
Withdrawal by Subject
1
0
1
1

Baseline Characteristics

Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Type 2 Diabetes
n=14 Participants
High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study. Low carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study. Baseline characteristics of all subjects with Type 2 Diabetes reported.
Participants Without Diabetes
n=15 Participants
High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet \[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study. Low carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet \[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\] for 3 days prior to the overnight study. Baseline characteristics of all subjects without Diabetes reported.
Total
n=29 Participants
Total of all reporting groups
Age, Continuous
63.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
54.5 years
STANDARD_DEVIATION 14.0 • n=7 Participants
58.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
9 Participants
n=7 Participants
15 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
12 Participants
n=5 Participants
15 Participants
n=7 Participants
27 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Body Weight (Kg)
82.4 Kg
STANDARD_DEVIATION 11.0 • n=5 Participants
82.5 Kg
STANDARD_DEVIATION 12.5 • n=7 Participants
82.4 Kg
STANDARD_DEVIATION 11.6 • n=5 Participants
BMI (Kg/m^2)
28.0 Kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
28.5 Kg/m^2
STANDARD_DEVIATION 2.9 • n=7 Participants
28.2 Kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
Fasting Plasma Glucose (mmol/L)
8.0 mmol/L
STANDARD_DEVIATION 3.5 • n=5 Participants
4.7 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
6.3 mmol/L
STANDARD_DEVIATION 2.9 • n=5 Participants
HbA1C
7.1 % of Glycosylated Haemoglobin
STANDARD_DEVIATION 1.4 • n=5 Participants
5.3 % of Glycosylated Haemoglobin
STANDARD_DEVIATION 0.4 • n=7 Participants
6.2 % of Glycosylated Haemoglobin
STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

Population: Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes.

We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.

Outcome measures

Outcome measures
Measure
Type 2 Diabetes - Glycogen Loading
n=14 Participants
Type 2 Diabetes after a Glycogen Loading meal
Type 2 Diabetes - Non-Glycogen Loading
n=13 Participants
Type 2 Diabetes after a Non-Glycogen Loading meal
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
GNG (umol/kgFFM/min)
8.2 umol/kgFFM/min
Interval 7.0 to 9.4
9.4 umol/kgFFM/min
Interval 8.2 to 10.5
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes
EGP (umol/kgFFM/min)
17.4 umol/kgFFM/min
Interval 16.0 to 18.7
15.6 umol/kgFFM/min
Interval 14.2 to 17.0

SECONDARY outcome

Timeframe: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

Population: Glycogenolysis (GGL) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes.

Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.

Outcome measures

Outcome measures
Measure
Type 2 Diabetes - Glycogen Loading
n=14 Participants
Type 2 Diabetes after a Glycogen Loading meal
Type 2 Diabetes - Non-Glycogen Loading
n=13 Participants
Type 2 Diabetes after a Non-Glycogen Loading meal
Rates of Glycogenolysis in Subjects With Type 2 Diabetes
GGL (umol/kgFFM/min)
9.2 umol/kgFFM/min
Interval 7.6 to 10.8
6.3 umol/kgFFM/min
Interval 4.7 to 7.9
Rates of Glycogenolysis in Subjects With Type 2 Diabetes
EGP (umol/kgFFM/min)
17.4 umol/kgFFM/min
Interval 16.0 to 18.7
15.6 umol/kgFFM/min
Interval 14.2 to 17.0

SECONDARY outcome

Timeframe: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

Population: Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects without diabetes.

Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.

Outcome measures

Outcome measures
Measure
Type 2 Diabetes - Glycogen Loading
n=13 Participants
Type 2 Diabetes after a Glycogen Loading meal
Type 2 Diabetes - Non-Glycogen Loading
n=14 Participants
Type 2 Diabetes after a Non-Glycogen Loading meal
Rates of Gluconeogenesis in Healthy Subjects
GNG (umol/kgFFM/min)
7.7 umol/kgFFM/min
Interval 6.5 to 8.9
8.5 umol/kgFFM/min
Interval 7.3 to 9.7
Rates of Gluconeogenesis in Healthy Subjects
EGP(umol/kgFFM/min)
15.9 umol/kgFFM/min
Interval 14.5 to 17.2
13.5 umol/kgFFM/min
Interval 12.1 to 14.8

Adverse Events

Type 2 Diabetes - GL Then NGL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Type 2 Diabetes - NGL Then GL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Participants Without Diabetes - GL Then NGL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Participants Without Diabetes - NGL Then GL

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

Dr. Rita Basu

University of Alabama at Birmingham

Phone: 2059341200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place