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Trial Outcomes & Findings for The Effects of Glycemic Optimization Before Gastric Bypass Surgery (NCT NCT01353118)

NCT ID: NCT01353118

Last Updated: 2022-03-14

Results Overview

A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission. The outcome measure is calculated as the count of participants achiving the above criteria

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

1 year

Results posted on

2022-03-14

Participant Flow

Participant milestones

Participant milestones
Measure
Gastric Bypass
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Gastric Bypass 2
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia gastric bypass: Optimise glucose control within 3 months before operation
Overall Study
STARTED
21
20
Overall Study
COMPLETED
21
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Glycemic Optimization Before Gastric Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Gastric Bypass
n=21 Participants
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Gastric Bypass 2
n=20 Participants
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia gastric bypass: Optimise glucose control within 3 months before operation
Total
n=41 Participants
Total of all reporting groups
Age, Customized
Age
49 years
STANDARD_DEVIATION 5 • n=5 Participants
48.5 years
STANDARD_DEVIATION 6 • n=7 Participants
48.75 years
STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
11 Participants
n=7 Participants
21 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
9 Participants
n=7 Participants
20 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
21 Participants
n=5 Participants
20 Participants
n=7 Participants
41 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
HbA1C
10.3 %
STANDARD_DEVIATION 1.2 • n=5 Participants
9.9 %
STANDARD_DEVIATION 1.1 • n=7 Participants
10.1 %
STANDARD_DEVIATION 1.15 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission. The outcome measure is calculated as the count of participants achiving the above criteria

Outcome measures

Outcome measures
Measure
Gastric Bypass
n=21 Participants
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Gastric Bypass 2
n=20 Participants
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia gastric bypass: Optimise glucose control within 3 months before operation
Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
6 Participants
6 Participants

SECONDARY outcome

Timeframe: 1 year

A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy. The outcome measure is calculated as the count of participants developing any of the microvascular events.

Outcome measures

Outcome measures
Measure
Gastric Bypass
n=21 Participants
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Gastric Bypass 2
n=20 Participants
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia gastric bypass: Optimise glucose control within 3 months before operation
A Composite of Microvascular Complications
0 Participants
0 Participants

Adverse Events

Gastric Bypass

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Gastric Bypass 2

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Gastric Bypass
n=21 participants at risk
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Gastric Bypass 2
n=20 participants at risk
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia gastric bypass: Optimise glucose control within 3 months before operation
Endocrine disorders
Hypoglycaemia
4.8%
1/21 • Number of events 1 • 1 year
Not different
5.0%
1/20 • Number of events 1 • 1 year
Not different
Gastrointestinal disorders
Abdominal pain
4.8%
1/21 • Number of events 1 • 1 year
Not different
0.00%
0/20 • 1 year
Not different

Additional Information

Carel le Roux

Imperial College

Phone: 07970719453

Results disclosure agreements

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